Capacitive coupled return path pad with separable array elements

ABSTRACT

A return pad of an electrosurgical system is disclosed. The return pad includes a plurality of conductive members and a plurality of sensing devices. The conductive members are configured to receive radio frequency current applied to a patient. The sensing devices are configured to detect at least one of the following: a nerve control signal applied to the patient; and a movement of an anatomical feature of the patient resulting from application of the nerve control signal.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation application claiming priority under35 U.S.C. § 120 to U.S. patent application Ser. No. 16/024,090, entitledCAPACITIVE COUPLED RETURN PATH PAD WITH SEPARABLE ARRAY ELEMENTS, filedJun. 29, 2018, now U.S. Patent Application Publication No. 2019/0201090,which claims the benefit under 35 U.S.C. § 119(e) of the earlier filingdate of U.S. Provisional Patent Application No. 62/650,898 filed on Mar.30, 2018, titled CAPACITIVE COUPLED RETURN PATH PAD WITH SEPARABLE ARRAYELEMENTS, the disclosure of each of which is hereby incorporated byreference in its entirety.

This application is a continuation application claiming priority under35 U.S.C. § 120 to U.S. patent application Ser. No. 16/024,090, entitledCAPACITIVE COUPLED RETURN PATH PAD WITH SEPARABLE ARRAY ELEMENTS, filedJun. 29, 2018, now U.S. Patent Application Publication No. 2019/0201090,which also claims the benefit of priority under 35 U.S.C. § 119(e) toU.S. Provisional Patent Application Ser. No. 62/650,887, titled SURGICALSYSTEMS WITH OPTIMIZED SENSING CAPABILITIES, filed Mar. 30, 2018, toU.S. Provisional Patent Application Ser. No. 62/650,877, titled SURGICALSMOKE EVACUATION SENSING AND CONTROLS, filed Mar. 30, 2018, and to U.S.Provisional Patent Application Ser. No. 62/650,882, titled SMOKEEVACUATION MODULE FOR INTERACTIVE SURGICAL PLATFORM, filed Mar. 30,2018, the disclosure of each of which is herein incorporated byreference in its entirety.

This application is a continuation application claiming priority under35 U.S.C. § 120 to U.S. patent application Ser. No. 16/024,090, entitledCAPACITIVE COUPLED RETURN PATH PAD WITH SEPARABLE ARRAY ELEMENTS, filedJun. 29, 2018, now U.S. Patent Application Publication No. 2019/0201090,which also claims the benefit of priority under 35 U.S.C. § 119(e) toU.S. Provisional Patent Application Ser. No. 62/640,417, titledTEMPERATURE CONTROL IN ULTRASONIC DEVICE AND CONTROL SYSTEM THEREFOR,filed Mar. 8, 2018, and to Provisional Patent Application Ser. No.62/640,415, titled ESTIMATING STATE OF ULTRASONIC END EFFECTOR ANDCONTROL SYSTEM THEREFOR, filed Mar. 8, 2018, the disclosure of each ofwhich is herein incorporated by reference in its entirety.

This application is a continuation application claiming priority under35 U.S.C. § 120 to U.S. patent application Ser. No. 16/024,090, entitledCAPACITIVE COUPLED RETURN PATH PAD WITH SEPARABLE ARRAY ELEMENTS, filedJun. 29, 2018, now U.S. Patent Application Publication No. 2019/0201090,which also claims the benefit of priority under 35 U.S.C. § 119(e) toU.S. Provisional Patent Application Ser. No. 62/611,341, titledINTERACTIVE SURGICAL PLATFORM, filed Dec. 28, 2017, to U.S. ProvisionalPatent Application Ser. No. 62/611,340, titled CLOUD-BASED MEDICALANALYTICS, filed Dec. 28, 2017, and to U.S. Provisional PatentApplication Ser. No. 62/611,339, titled ROBOT ASSISTED SURGICALPLATFORM, filed Dec. 28, 2017, the disclosure of each of which is hereinincorporated by reference in its entirety.

BACKGROUND

This application discloses an invention which is related, generally andin various aspects, to surgical systems and return pads ofelectrosurgical systems.

Electrosurgical systems typically utilize a generator to supplyelectrosurgical energy (e.g., alternating current at radiofrequencylevels) to an active electrode which applies the electrosurgical energyto a patient's body. The electrosurgical energy applied to the patient'sbody operates to heat tissue of the patient (to seal and/or cut thetissue) and generally exits the patient's body to a return pad which canbe applied to the patient's body or can be capacitively coupled to thepatient's body. The return pad is connected to return path wiring whichin turn is connected back to the generator. Stated differently, thereturn pad and the return path wiring collectively form the electricalreturn path of the electrosurgical system.

One concern associated with electrosurgery is whether the dispersiveelectrode of the return pad is large enough and/or has sufficientsurface area to adequately capture and carry the electrosurgical energyintroduced into the patient's body so that unwanted burning of thepatient can be avoided. The return pad is generally sized to keep thecurrent density sufficiently low as the electrosurgical energy exits thepatient. Otherwise, heat can build up within the patient and can resultin a burn.

When electrosurgical energy is utilized to cut targeted tissue of thepatient, one concern is that one or more nerves may be inadvertentlyinjured and/or severed during the electrosurgery, potentially resultingin the patient experiencing muscle weakness, pain, numbness, paralysisand/or other undesired outcomes. Although surgeons generally have a goodidea of where nerves are located and are thus able to avoid them, thisis not always the case. For example, if an area of a patient isdeformed, damaged or otherwise deviates from what is considered normal,determining the location of a given nerve within the area can bedifficult. When the location of a given nerve within the area is notreadily discernible, the likelihood of inadvertently injuring orsevering the nerve is increased.

SUMMARY

In one aspect, a return pad of an electrosurgical system is provided.The return pad comprising: a plurality of conductive members configuredto receive radio frequency current applied to a patient; and a pluralityof sensing devices configured to detect at least one of the following: anerve control signal applied to the patient; and a movement of ananatomical feature of the patient resulting from application of thenerve control signal.

In another aspect, an electrosurgical system is provided. Theelectrosurgical system comprising: a generator configured to supply analternating current at a radiofrequency; an instrument configured toapply the alternating current to a patient; a return pad capacitivelycouplable to the patient, wherein the return pad comprises: a pluralityof conductive members configured to conduct radio frequency current,wherein the plurality of conductive members are capacitively couplableto a patient and are selectively couplable to the generator; a pluralityof sensing devices configured to detect at least one of the following: anerve control signal applied to the patient; and a movement of ananatomical feature of the patient resulting from application of thenerve control signal; and a conductor coupled to the return pad and thegenerator

In yet another aspect, a return pad of an electrosurgical system isprovided. The return pad comprising: a plurality of electrodesconfigured for capacitive coupling with a patient; and an array ofsensing devices configured to detect at least one of the following: anerve control signal applied to the patient; and a movement of ananatomical feature of the patient resulting from application of thenerve control signal.

BRIEF DESCRIPTION OF THE DRAWINGS

The features of various aspects are set forth with particularity in theappended claims. The various aspects, however, both as to organizationand methods of operation, together with further objects and advantagesthereof, may best be understood by reference to the followingdescription, taken in conjunction with the accompanying drawings asfollows.

FIG. 1 is a block diagram of a computer-implemented interactive surgicalsystem, in accordance with at least one aspect of the presentdisclosure.

FIG. 2 is a surgical system being used to perform a surgical procedurein an operating room, in accordance with at least one aspect of thepresent disclosure.

FIG. 3 is a surgical hub paired with a visualization system, a roboticsystem, and an intelligent instrument, in accordance with at least oneaspect of the present disclosure.

FIG. 4 is a partial perspective view of a surgical hub enclosure, and ofa combo generator module slidably receivable in a drawer of the surgicalhub enclosure, in accordance with at least one aspect of the presentdisclosure.

FIG. 5 is a perspective view of a combo generator module with bipolar,ultrasonic, and monopolar contacts and a smoke evacuation component, inaccordance with at least one aspect of the present disclosure.

FIG. 6 illustrates individual power bus attachments for a plurality oflateral docking ports of a lateral modular housing configured to receivea plurality of modules, in accordance with at least one aspect of thepresent disclosure.

FIG. 7 illustrates a vertical modular housing configured to receive aplurality of modules, in accordance with at least one aspect of thepresent disclosure.

FIG. 8 illustrates a surgical data network comprising a modularcommunication hub configured to connect modular devices located in oneor more operating theaters of a healthcare facility, or any room in ahealthcare facility specially equipped for surgical operations, to thecloud, in accordance with at least one aspect of the present disclosure.

FIG. 9 illustrates a computer-implemented interactive surgical system,in accordance with at least one aspect of the present disclosure.

FIG. 10 illustrates a surgical hub comprising a plurality of modulescoupled to the modular control tower, in accordance with at least oneaspect of the present disclosure.

FIG. 11 illustrates one aspect of a Universal Serial Bus (USB) networkhub device, in accordance with at least one aspect of the presentdisclosure.

FIG. 12 illustrates a logic diagram of a control system of a surgicalinstrument or tool, in accordance with at least one aspect of thepresent disclosure.

FIG. 13 illustrates a control circuit configured to control aspects ofthe surgical instrument or tool, in accordance with at least one aspectof the present disclosure.

FIG. 14 illustrates a combinational logic circuit configured to controlaspects of the surgical instrument or tool, in accordance with at leastone aspect of the present disclosure.

FIG. 15 illustrates a sequential logic circuit configured to controlaspects of the surgical instrument or tool, in accordance with at leastone aspect of the present disclosure.

FIG. 16 illustrates a surgical instrument or tool comprising a pluralityof motors which can be activated to perform various functions, inaccordance with at least one aspect of the present disclosure.

FIG. 17 is a schematic diagram of a robotic surgical instrumentconfigured to operate a surgical tool described herein, in accordancewith at least one aspect of the present disclosure.

FIG. 18 illustrates a block diagram of a surgical instrument programmedto control the distal translation of a displacement member, inaccordance with at least one aspect of the present disclosure.

FIG. 19 is a schematic diagram of a surgical instrument configured tocontrol various functions, in accordance with at least one aspect of thepresent disclosure.

FIG. 20 is a simplified block diagram of a generator configured toprovide inductorless tuning, among other benefits, in accordance with atleast one aspect of the present disclosure.

FIG. 21 illustrates an example of a generator, which is one form of thegenerator of FIG. 20, in accordance with at least one aspect of thepresent disclosure.

FIG. 22 illustrates an electrosurgical system, in accordance with atleast one aspect of the present disclosure.

FIG. 23 illustrates a return pad of the electrosurgical system of FIG.22, in accordance with at least one aspect of the present disclosure.

FIG. 24 illustrates a plurality of electrodes of the return pad of FIG.23, in accordance with at least one aspect of the present disclosure.

FIG. 25 illustrates an array of sensing devices of the return pad ofFIG. 23, in accordance with at least one aspect of the presentdisclosure.

FIG. 26 illustrates a method for concurrently applying a nervestimulation signal and electrosurgical energy to a patient, inaccordance with at least one aspect of the present disclosure.

DETAILED DESCRIPTION

Applicant of the present application owns the following U.S. PatentApplications, filed on Jun. 29, 2018, the disclosure of each of which isherein incorporated by reference in its entirety:

-   -   U.S. patent application Ser. No. 16/024,057, titled CONTROLLING        A SURGICAL INSTRUMENT ACCORDING TO SENSED CLOSURE PARAMETERS,        now U.S. Pat. No. 10,695,081;    -   U.S. patent application Ser. No. 16/024,067, titled SYSTEMS FOR        ADJUSTING END EFFECTOR PARAMETERS BASED ON PERIOPERATIVE        INFORMATION, now U.S. Pat. No. 10,595,887;    -   U.S. patent application Ser. No. 16/024,075, titled SAFETY        SYSTEMS FOR SMART POWERED SURGICAL STAPLING, now U.S. Patent        Application Publication No. 2019/0201146;    -   U.S. patent application Ser. No. 16/024,083, titled SAFETY        SYSTEMS FOR SMART POWERED SURGICAL STAPLING, now U.S. Patent        Application Publication No. 2019/0200984;    -   U.S. patent application Ser. No. 16/024,094, titled SURGICAL        SYSTEMS FOR DETECTING END EFFECTOR TISSUE DISTRIBUTION        IRREGULARITIES, now U.S. Pat. No. 11,311,306;    -   U.S. patent application Ser. No. 16/024,138, titled SYSTEMS FOR        DETECTING PROXIMITY OF SURGICAL END EFFECTOR TO CANCEROUS        TISSUE, now U.S. Patent Application Publication No.        2019/0200985;    -   U.S. patent application Ser. No. 16/024,150, titled SURGICAL        INSTRUMENT CARTRIDGE SENSOR ASSEMBLIES, now U.S. Patent        Application Publication No. 2019/0200986;    -   U.S. patent application Ser. No. 16/024,160, titled VARIABLE        OUTPUT CARTRIDGE SENSOR ASSEMBLY, now U.S. Patent Application        Publication No. 2019/0200987;    -   U.S. patent application Ser. No. 16/024,124, titled SURGICAL        INSTRUMENT HAVING A FLEXIBLE ELECTRODE, now U.S. Pat. No.        11,284,936;    -   U.S. patent application Ser. No. 16/024,132, titled SURGICAL        INSTRUMENT HAVING A FLEXIBLE CIRCUIT, now U.S. Patent        Application Publication No. 2019/0201021;    -   U.S. patent application Ser. No. 16/024,141, titled SURGICAL        INSTRUMENT WITH A TISSUE MARKING ASSEMBLY, now U.S. Pat. No.        11,114,195;    -   U.S. patent application Ser. No. 16/024,162, titled SURGICAL        SYSTEMS WITH PRIORITIZED DATA TRANSMISSION CAPABILITIES, now        U.S. Patent Application Publication No. 2019/0200988;    -   U.S. patent application Ser. No. 16/024,066, titled SURGICAL        EVACUATION SENSING AND MOTOR CONTROL, now U.S. Pat. No.        11,160,605;    -   U.S. patent application Ser. No. 16/024,096, titled SURGICAL        EVACUATION SENSOR ARRANGEMENTS, now U.S. Patent Application        Publication No. 2019/0201083;    -   U.S. patent application Ser. No. 16/024,116, titled SURGICAL        EVACUATION FLOW PATHS, now U.S. Pat. No. 11,051,876;    -   U.S. patent application Ser. No. 16/024,149, titled SURGICAL        EVACUATION SENSING AND GENERATOR CONTROL, now U.S. Patent        Application Publication No. 2019/0201085;    -   U.S. patent application Ser. No. 16/024,180, titled SURGICAL        EVACUATION SENSING AND DISPLAY, now U.S. Pat. No. 11,304,745;    -   U.S. patent application Ser. No. 16/024,245, titled        COMMUNICATION OF SMOKE EVACUATION SYSTEM PARAMETERS TO HUB OR        CLOUD IN SMOKE EVACUATION MODULE FOR INTERACTIVE SURGICAL        PLATFORM, now U.S. Pat. No. 10,755,813;    -   U.S. patent application Ser. No. 16/024,258, titled SMOKE        EVACUATION SYSTEM INCLUDING A SEGMENTED CONTROL CIRCUIT FOR        INTERACTIVE SURGICAL PLATFORM, now U.S. Patent Application        Publication No. 2019/0201087;    -   U.S. patent application Ser. No. 16/024,265, titled SURGICAL        EVACUATION SYSTEM WITH A COMMUNICATION CIRCUIT FOR COMMUNICATION        BETWEEN A FILTER AND A SMOKE EVACUATION DEVICE, now U.S. Pat.        No. 10,898,622; and    -   U.S. patent application Ser. No. 16/024,273, titled DUAL        IN-SERIES LARGE AND SMALL DROPLET FILTERS, now U.S. Pat. No.        11,045,591.

Applicant of the present application owns the following U.S. ProvisionalPatent Applications, filed on Jun. 28, 2018, the disclosure of each ofwhich is herein incorporated by reference in its entirety:

-   -   U.S. Provisional Patent Application Ser. No. 62/691,228, titled        A METHOD OF USING REINFORCED FLEX CIRCUITS WITH MULTIPLE SENSORS        WITH ELECTROSURGICAL DEVICES;    -   U.S. Provisional Patent Application Ser. No. 62/691,227, titled        CONTROLLING A SURGICAL INSTRUMENT ACCORDING TO SENSED CLOSURE        PARAMETERS;    -   U.S. Provisional Patent Application Ser. No. 62/691,230, titled        SURGICAL INSTRUMENT HAVING A FLEXIBLE ELECTRODE;    -   U.S. Provisional Patent Application Ser. No. 62/691,219, titled        SURGICAL EVACUATION SENSING AND MOTOR CONTROL;    -   U.S. Provisional Patent Application Ser. No. 62/691,257, titled        COMMUNICATION OF SMOKE EVACUATION SYSTEM PARAMETERS TO HUB OR        CLOUD IN SMOKE EVACUATION MODULE FOR INTERACTIVE SURGICAL        PLATFORM;    -   U.S. Provisional Patent Application Ser. No. 62/691,262, titled        SURGICAL EVACUATION SYSTEM WITH A COMMUNICATION CIRCUIT FOR        COMMUNICATION BETWEEN A FILTER AND A SMOKE EVACUATION DEVICE;        and    -   U.S. Provisional Patent Application Ser. No. 62/691,251, titled        DUAL IN-SERIES LARGE AND SMALL DROPLET FILTERS.

Applicant of the present application owns the following U.S. ProvisionalPatent Application, filed on Apr. 19, 2018, the disclosure of which isherein incorporated by reference in its entirety:

-   -   U.S. Provisional Patent Application Ser. No. 62/659,900, titled        METHOD OF HUB COMMUNICATION.

Applicant of the present application owns the following U.S. PatentApplications, filed on Mar. 29, 2018, the disclosure of each of which isherein incorporated by reference in its entirety:

-   -   U.S. patent application Ser. No. 15/940,641, titled INTERACTIVE        SURGICAL SYSTEMS WITH ENCRYPTED COMMUNICATION CAPABILITIES;    -   U.S. patent application Ser. No. 15/940,648, titled INTERACTIVE        SURGICAL SYSTEMS WITH CONDITION HANDLING OF DEVICES AND DATA        CAPABILITIES;    -   U.S. patent application Ser. No. 15/940,656, titled SURGICAL HUB        COORDINATION OF CONTROL AND COMMUNICATION OF OPERATING ROOM        DEVICES;    -   U.S. patent application Ser. No. 15/940,666, titled SPATIAL        AWARENESS OF SURGICAL HUBS IN OPERATING ROOMS;    -   U.S. patent application Ser. No. 15/940,670, titled COOPERATIVE        UTILIZATION OF DATA DERIVED FROM SECONDARY SOURCES BY        INTELLIGENT SURGICAL HUBS;    -   U.S. patent application Ser. No. 15/940,677, titled SURGICAL HUB        CONTROL ARRANGEMENTS;    -   U.S. patent application Ser. No. 15/940,632, titled DATA        STRIPPING METHOD TO INTERROGATE PATIENT RECORDS AND CREATE        ANONYMIZED RECORD;    -   U.S. patent application Ser. No. 15/940,640, titled        COMMUNICATION HUB AND STORAGE DEVICE FOR STORING PARAMETERS AND        STATUS OF A SURGICAL DEVICE TO BE SHARED WITH CLOUD BASED        ANALYTICS SYSTEMS;    -   U.S. patent application Ser. No. 15/940,645, titled SELF        DESCRIBING DATA PACKETS GENERATED AT AN ISSUING INSTRUMENT;    -   U.S. patent application Ser. No. 15/940,649, titled DATA PAIRING        TO INTERCONNECT A DEVICE MEASURED PARAMETER WITH AN OUTCOME;    -   U.S. patent application Ser. No. 15/940,654, titled SURGICAL HUB        SITUATIONAL AWARENESS;    -   U.S. patent application Ser. No. 15/940,663, titled SURGICAL        SYSTEM DISTRIBUTED PROCESSING;    -   U.S. patent application Ser. No. 15/940,668, titled AGGREGATION        AND REPORTING OF SURGICAL HUB DATA;    -   U.S. patent application Ser. No. 15/940,671, titled SURGICAL HUB        SPATIAL AWARENESS TO DETERMINE DEVICES IN OPERATING THEATER;    -   U.S. patent application Ser. No. 15/940,686, titled DISPLAY OF        ALIGNMENT OF STAPLE CARTRIDGE TO PRIOR LINEAR STAPLE LINE;    -   U.S. patent application Ser. No. 15/940,700, titled STERILE        FIELD INTERACTIVE CONTROL DISPLAYS;    -   U.S. patent application Ser. No. 15/940,629, titled COMPUTER        IMPLEMENTED INTERACTIVE SURGICAL SYSTEMS;    -   U.S. patent application Ser. No. 15/940,704, titled USE OF LASER        LIGHT AND RED-GREEN-BLUE COLORATION TO DETERMINE PROPERTIES OF        BACK SCATTERED LIGHT;    -   U.S. patent application Ser. No. 15/940,722, titled        CHARACTERIZATION OF TISSUE IRREGULARITIES THROUGH THE USE OF        MONO-CHROMATIC LIGHT REFRACTIVITY; and    -   U.S. patent application Ser. No. 15/940,742, titled DUAL CMOS        ARRAY IMAGING.

Applicant of the present application owns the following U.S. PatentApplications, filed on Mar. 29, 2018, the disclosure of each of which isherein incorporated by reference in its entirety:

-   -   U.S. patent application Ser. No. 15/940,636, titled ADAPTIVE        CONTROL PROGRAM UPDATES FOR SURGICAL DEVICES;    -   U.S. patent application Ser. No. 15/940,653, titled ADAPTIVE        CONTROL PROGRAM UPDATES FOR SURGICAL HUBS;    -   U.S. patent application Ser. No. 15/940,660, titled CLOUD-BASED        MEDICAL ANALYTICS FOR CUSTOMIZATION AND RECOMMENDATIONS TO A        USER;    -   U.S. patent application Ser. No. 15/940,679, titled CLOUD-BASED        MEDICAL ANALYTICS FOR LINKING OF LOCAL USAGE TRENDS WITH THE        RESOURCE ACQUISITION BEHAVIORS OF LARGER DATA SET;    -   U.S. patent application Ser. No. 15/940,694, titled CLOUD-BASED        MEDICAL ANALYTICS FOR MEDICAL FACILITY SEGMENTED        INDIVIDUALIZATION OF INSTRUMENT FUNCTION;    -   U.S. patent application Ser. No. 15/940,634, titled CLOUD-BASED        MEDICAL ANALYTICS FOR SECURITY AND AUTHENTICATION TRENDS AND        REACTIVE MEASURES;    -   U.S. patent application Ser. No. 15/940,706, titled DATA        HANDLING AND PRIORITIZATION IN A CLOUD ANALYTICS NETWORK; and    -   U.S. patent application Ser. No. 15/940,675, titled CLOUD        INTERFACE FOR COUPLED SURGICAL DEVICES.

Applicant of the present application owns the following U.S. PatentApplications, filed on Mar. 29, 2018, the disclosure of each of which isherein incorporated by reference in its entirety:

-   -   U.S. patent application Ser. No. 15/940,627, titled DRIVE        ARRANGEMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS;    -   U.S. patent application Ser. No. 15/940,637, titled        COMMUNICATION ARRANGEMENTS FOR ROBOT-ASSISTED SURGICAL        PLATFORMS;    -   U.S. patent application Ser. No. 15/940,642, titled CONTROLS FOR        ROBOT-ASSISTED SURGICAL PLATFORMS;    -   U.S. patent application Ser. No. 15/940,676, titled AUTOMATIC        TOOL ADJUSTMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS;    -   U.S. patent application Ser. No. 15/940,680, titled CONTROLLERS        FOR ROBOT-ASSISTED SURGICAL PLATFORMS;    -   U.S. patent application Ser. No. 15/940,683, titled COOPERATIVE        SURGICAL ACTIONS FOR ROBOT-ASSISTED SURGICAL PLATFORMS;    -   U.S. patent application Ser. No. 15/940,690, titled DISPLAY        ARRANGEMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS; and    -   U.S. patent application Ser. No. 15/940,711, titled SENSING        ARRANGEMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS.

Applicant of the present application owns the following U.S. ProvisionalPatent Applications, filed on Mar. 28, 2018, the disclosure of each ofwhich is herein incorporated by reference in its entirety:

-   -   U.S. Provisional Patent Application Ser. No. 62/649,302, titled        INTERACTIVE SURGICAL SYSTEMS WITH ENCRYPTED COMMUNICATION        CAPABILITIES;    -   U.S. Provisional Patent Application Ser. No. 62/649,294, titled        DATA STRIPPING METHOD TO INTERROGATE PATIENT RECORDS AND CREATE        ANONYMIZED RECORD;    -   U.S. Provisional Patent Application Ser. No. 62/649,300, titled        SURGICAL HUB SITUATIONAL AWARENESS;    -   U.S. Provisional Patent Application Ser. No. 62/649,309, titled        SURGICAL HUB SPATIAL AWARENESS TO DETERMINE DEVICES IN OPERATING        THEATER;    -   U.S. Provisional Patent Application Ser. No. 62/649,310, titled        COMPUTER IMPLEMENTED INTERACTIVE SURGICAL SYSTEMS;    -   U.S. Provisional Patent Application Ser. No. 62/649,291, titled        USE OF LASER LIGHT AND RED-GREEN-BLUE COLORATION TO DETERMINE        PROPERTIES OF BACK SCATTERED LIGHT;    -   U.S. Provisional Patent Application Ser. No. 62/649,296, titled        ADAPTIVE CONTROL PROGRAM UPDATES FOR SURGICAL DEVICES;    -   U.S. Provisional Patent Application Ser. No. 62/649,333, titled        CLOUD-BASED MEDICAL ANALYTICS FOR CUSTOMIZATION AND        RECOMMENDATIONS TO A USER;    -   U.S. Provisional Patent Application Ser. No. 62/649,327, titled        CLOUD-BASED MEDICAL ANALYTICS FOR SECURITY AND AUTHENTICATION        TRENDS AND REACTIVE MEASURES;    -   U.S. Provisional Patent Application Ser. No. 62/649,315, titled        DATA HANDLING AND PRIORITIZATION IN A CLOUD ANALYTICS NETWORK;    -   U.S. Provisional Patent Application Ser. No. 62/649,313, titled        CLOUD INTERFACE FOR COUPLED SURGICAL DEVICES;    -   U.S. Provisional Patent Application Ser. No. 62/649,320, titled        DRIVE ARRANGEMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS;    -   U.S. Provisional Patent Application Ser. No. 62/649,307, titled        AUTOMATIC TOOL ADJUSTMENTS FOR ROBOT-ASSISTED SURGICAL        PLATFORMS; and    -   U.S. Provisional Patent Application Ser. No. 62/649,323, titled        SENSING ARRANGEMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS.

It is to be understood that at least some of the figures anddescriptions of the invention have been simplified to illustrateelements that are relevant for a clear understanding of the invention,while eliminating, for purposes of clarity, other elements that those ofordinary skill in the art will appreciate may also comprise a portion ofthe invention. However, because such elements are well known in the art,and because they do not facilitate a better understanding of theinvention, a description of such elements is not provided herein.

In the following detailed description, reference is made to theaccompanying drawings, which form a part hereof. In the drawings,similar symbols and reference characters typically identify similarcomponents throughout several views, unless context dictates otherwise.The illustrative aspects described in the detailed description, drawingsand claims are not meant to be limiting. Other aspects may be utilized,and other changes may be made, without departing from the scope of thetechnology described herein.

The following description of certain examples of the technology shouldnot be used to limit its scope. Other examples, features, aspects,embodiments and advantages of the technology will become apparent tothose skilled in the art from the following description, which is by wayof illustration, one of the best modes contemplated for carrying out thetechnology. As will be realized, the technology described herein iscapable of other different and obvious aspects, all without departingfrom the technology. Accordingly, the drawings and descriptions shouldbe regarded as illustrative in nature and not restrictive.

It is further understood that any one or more of the teachings,expressions, aspects, embodiments, examples, etc. described herein maybe combined with any one or more of the other teachings, expressions,aspects, embodiments, examples, etc. that are described herein. Thefollowing described teachings, expressions, aspects, embodiments,examples, etc. should therefore not be viewed in isolation relative toeach other. Various suitable ways in which the teachings herein may becombined will be readily apparent to those of ordinary skill in the artin view of the teachings herein. Such modifications and variations areintended to be included within the scope of the claims.

Before explaining the various aspects of the electrosurgical system, thereturn pad and the method in detail, it should be noted that the variousaspects disclosed herein are not limited in their application or use tothe details of construction and arrangement of parts illustrated in theaccompanying drawings and description. Rather, the disclosed aspects maybe positioned or incorporated in other aspects, embodiments, variationsand modifications thereof, and may be practiced or carried out invarious ways. Accordingly, aspects of the electrosurgical system, returnpad and method disclosed herein are illustrative in nature and are notmeant to limit the scope or application thereof. Furthermore, unlessotherwise indicated, the terms and expressions employed herein have beenchosen for the purpose of describing the aspects for the convenience ofthe reader and are not meant to limit the scope thereof. In addition, itshould be understood that any one or more of the disclosed aspects,expressions of aspects, and/or examples thereof, can be combined withany one or more of the other disclosed aspects, expressions of aspects,and/or examples thereof, without limitation.

Also, in the following description, it is to be understood that termssuch as inward, outward, upward, downward, above, below, left, right,interior, exterior and the like are words of convenience and are not tobe construed as limiting terms. Terminology used herein is not meant tobe limiting insofar as devices described herein, or portions thereof,may be attached or utilized in other orientations. The various aspectswill be described in more detail with reference to the drawings.

As described in more detail hereinbelow, aspects of the invention may beimplemented by a computing device and/or a computer program stored on acomputer-readable medium. The computer-readable medium may comprise adisk, a device, and/or a propagated signal.

Referring to FIG. 1, a computer-implemented interactive surgical system100 includes one or more surgical systems 102 and a cloud-based system(e.g., the cloud 104 that may include a remote server 113 coupled to astorage device 105). Each surgical system 102 includes at least onesurgical hub 106 in communication with the cloud 104 that may include aremote server 113. In one example, as illustrated in FIG. 1, thesurgical system 102 includes a visualization system 108, a roboticsystem 110, and a handheld intelligent surgical instrument 112, whichare configured to communicate with one another and/or surgical hub 106.In some aspects, a surgical system 102 may include an M number of hubs106, an N number of visualization systems 108, an O number of roboticsystems 110, and a P number of handheld intelligent surgical instruments112, where M, N, O, and P are integers greater than or equal to one.

FIG. 3 depicts an example of a surgical system 102 being used to performa surgical procedure on a patient who is lying down on an operatingtable 114 in a surgical operating room 116. A robotic system 110 is usedin the surgical procedure as a part of the surgical system 102. Therobotic system 110 includes a surgeon's console 118, a patient side cart120 (surgical robot), and a surgical robotic hub 122. The patient sidecart 120 can manipulate at least one removably coupled surgical tool 117through a minimally invasive incision in the body of the patient whilethe surgeon views the surgical site through the surgeon's console 118.An image of the surgical site can be obtained by a medical imagingdevice 124, which can be manipulated by the patient side cart 120 toorient the imaging device 124. The robotic hub 122 can be used toprocess the images of the surgical site for subsequent display to thesurgeon through the surgeon's console 118.

Other types of robotic systems can be readily adapted for use with thesurgical system 102. Various examples of robotic systems and surgicaltools that are suitable for use with the present disclosure aredescribed in U.S. Provisional Patent Application Ser. No. 62/611,339,titled ROBOT ASSISTED SURGICAL PLATFORM, filed Dec. 28, 2017, thedisclosure of which is herein incorporated by reference in its entirety.

Various examples of cloud-based analytics that are performed by thecloud 104, and are suitable for use with the present disclosure, aredescribed in U.S. Provisional Patent Application Ser. No. 62/611,340,titled CLOUD-BASED MEDICAL ANALYTICS, filed Dec. 28, 2017, thedisclosure of which is herein incorporated by reference in its entirety.

In various aspects, the imaging device 124 includes at least one imagesensor and one or more optical components. Suitable image sensorsinclude, but are not limited to, Charge-Coupled Device (CCD) sensors andComplementary Metal-Oxide Semiconductor (CMOS) sensors.

The optical components of the imaging device 124 may include one or moreillumination sources and/or one or more lenses. The one or moreillumination sources may be directed to illuminate portions of thesurgical field. The one or more image sensors may receive lightreflected or refracted from the surgical field, including lightreflected or refracted from tissue and/or surgical instruments.

The one or more illumination sources may be configured to radiateelectromagnetic energy in the visible spectrum as well as the invisiblespectrum. The visible spectrum, sometimes referred to as the opticalspectrum or luminous spectrum, is that portion of the electromagneticspectrum that is visible to (i.e., can be detected by) the human eye andmay be referred to as visible light or simply light. A typical human eyewill respond to wavelengths in air that are from about 380 nm to about750 nm.

The invisible spectrum (i.e., the non-luminous spectrum) is that portionof the electromagnetic spectrum that lies below and above the visiblespectrum (i.e., wavelengths below about 380 nm and above about 750 nm).The invisible spectrum is not detectable by the human eye. Wavelengthsgreater than about 750 nm are longer than the red visible spectrum, andthey become invisible infrared (IR), microwave, and radioelectromagnetic radiation. Wavelengths less than about 380 nm areshorter than the violet spectrum, and they become invisible ultraviolet,x-ray, and gamma ray electromagnetic radiation.

In various aspects, the imaging device 124 is configured for use in aminimally invasive procedure. Examples of imaging devices suitable foruse with the present disclosure include, but not limited to, anarthroscope, angioscope, bronchoscope, choledochoscope, colonoscope,cytoscope, duodenoscope, enteroscope, esophagogastro-duodenoscope(gastroscope), endoscope, laryngoscope, nasopharyngo-neproscope,sigmoidoscope, thoracoscope, and ureteroscope.

In one aspect, the imaging device employs multi-spectrum monitoring todiscriminate topography and underlying structures. A multi-spectralimage is one that captures image data within specific wavelength rangesacross the electromagnetic spectrum. The wavelengths may be separated byfilters or by the use of instruments that are sensitive to particularwavelengths, including light from frequencies beyond the visible lightrange, e.g., IR and ultraviolet. Spectral imaging can allow extractionof additional information the human eye fails to capture with itsreceptors for red, green, and blue. The use of multi-spectral imaging isdescribed in greater detail under the heading “Advanced ImagingAcquisition Module” in U.S. Provisional Patent Application Ser. No.62/611,341, titled INTERACTIVE SURGICAL PLATFORM, filed Dec. 28, 2017,the disclosure of which is herein incorporated by reference in itsentirety. Multi-spectrum monitoring can be a useful tool in relocating asurgical field after a surgical task is completed to perform one or moreof the previously described tests on the treated tissue.

It is axiomatic that strict sterilization of the operating room andsurgical equipment is required during any surgery. The strict hygieneand sterilization conditions required in a “surgical theater,” i.e., anoperating or treatment room, necessitate the highest possible sterilityof all medical devices and equipment. Part of that sterilization processis the need to sterilize anything that comes in contact with the patientor penetrates the sterile field, including the imaging device 124 andits attachments and components. It will be appreciated that the sterilefield may be considered a specified area, such as within a tray or on asterile towel, that is considered free of microorganisms, or the sterilefield may be considered an area, immediately around a patient, who hasbeen prepared for a surgical procedure. The sterile field may includethe scrubbed team members, who are properly attired, and all furnitureand fixtures in the area.

In various aspects, the visualization system 108 includes one or moreimaging sensors, one or more image processing units, one or more storagearrays, and one or more displays that are strategically arranged withrespect to the sterile field, as illustrated in FIG. 2. In one aspect,the visualization system 108 includes an interface for HL7, PACS, andEMR. Various components of the visualization system 108 are describedunder the heading “Advanced Imaging Acquisition Module” in U.S.Provisional Patent Application Ser. No. 62/611,341, titled INTERACTIVESURGICAL PLATFORM, filed Dec. 28, 2017, the disclosure of which isherein incorporated by reference in its entirety.

As illustrated in FIG. 2, a primary display 119 is positioned in thesterile field to be visible to an operator at the operating table 114.In addition, a visualization tower 111 is positioned outside the sterilefield. The visualization tower 111 includes a first non-sterile display107 and a second non-sterile display 109, which face away from eachother. The visualization system 108, guided by surgical hub 106, isconfigured to utilize the displays 107, 109, and 119 to coordinateinformation flow to operators inside and outside the sterile field. Forexample, surgical hub 106 may cause the visualization system 108 todisplay a snap-shot of a surgical site, as recorded by an imaging device124, on a non-sterile display 107 or 109, while maintaining a live feedof the surgical site on the primary display 119. The snap-shot on thenon-sterile display 107 or 109 can permit a non-sterile operator toperform a diagnostic step relevant to the surgical procedure, forexample.

In one aspect, surgical hub 106 is also configured to route a diagnosticinput or feedback entered by a non-sterile operator at the visualizationtower 111 to the primary display 119 within the sterile field, where itcan be viewed by a sterile operator at the operating table. In oneexample, the input can be in the form of a modification to the snap-shotdisplayed on the non-sterile display 107 or 109, which can be routed tothe primary display 119 by surgical hub 106.

Referring to FIG. 2, a surgical instrument 112 is being used in thesurgical procedure as part of the surgical system 102. Surgical hub 106is also configured to coordinate information flow to a display of thesurgical instrument 112. For example, see U.S. Provisional PatentApplication Ser. No. 62/611,341, titled INTERACTIVE SURGICAL PLATFORM,filed Dec. 28, 2017, the disclosure of which is herein incorporated byreference in its entirety. A diagnostic input or feedback entered by anon-sterile operator at the visualization tower 111 can be routed bysurgical hub 106 to the surgical instrument display 115 within thesterile field, where it can be viewed by the operator of the surgicalinstrument 112. Example surgical instruments that are suitable for usewith the surgical system 102 are described under the heading “SurgicalInstrument Hardware” and in U.S. Provisional Patent Application Ser. No.62/611,341, titled INTERACTIVE SURGICAL PLATFORM, filed Dec. 28, 2017,the disclosure of which is herein incorporated by reference in itsentirety, for example.

Referring now to FIG. 3, a surgical hub 106 is depicted in communicationwith a visualization system 108, a robotic system 110, and a handheldintelligent surgical instrument 112. Surgical hub 106 includes asurgical hub display 135, an imaging module 138, a generator module 140,a communication module 130, a processor module 132, and a storage array134. In certain aspects, as illustrated in FIG. 3, surgical hub 106further includes a smoke evacuation module 126 and/or asuction/irrigation module 128.

During a surgical procedure, energy application to tissue, for sealingand/or cutting, is generally associated with smoke evacuation, suctionof excess fluid, and/or irrigation of the tissue. Fluid, power, and/ordata lines from different sources are often entangled during thesurgical procedure. Valuable time can be lost addressing this issueduring a surgical procedure. Detangling the lines may necessitatedisconnecting the lines from their respective modules, which may requireresetting the modules. Surgical hub modular enclosure 136 offers aunified environment for managing the power, data, and fluid lines, whichreduces the frequency of entanglement between such lines.

Aspects of the present disclosure present a surgical hub for use in asurgical procedure that involves energy application to tissue at asurgical site. The surgical hub includes a surgical hub enclosure and acombo generator module slidably receivable in a docking station ofsurgical hub enclosure. The docking station includes data and powercontacts. The combo generator module includes two or more of anultrasonic energy generator component, a bipolar RF energy generatorcomponent, and a monopolar RF energy generator component that are housedin a single unit. In one aspect, the combo generator module alsoincludes a smoke evacuation component, at least one energy deliverycable for connecting the combo generator module to a surgicalinstrument, at least one smoke evacuation component configured toevacuate smoke, fluid, and/or particulates generated by the applicationof therapeutic energy to the tissue, and a fluid line extending from theremote surgical site to the smoke evacuation component.

In one aspect, the fluid line is a first fluid line and a second fluidline extends from the remote surgical site to a suction and irrigationmodule slidably received in surgical hub enclosure. In one aspect,surgical hub enclosure comprises a fluid interface.

Certain surgical procedures may require the application of more than oneenergy type to the tissue. One energy type may be more beneficial forcutting the tissue, while another different energy type may be morebeneficial for sealing the tissue. For example, a bipolar generator canbe used to seal the tissue while an ultrasonic generator can be used tocut the sealed tissue. Aspects of the present disclosure present asolution where a surgical hub modular enclosure 136 is configured toaccommodate different generators, and facilitate an interactivecommunication therebetween. One of the advantages of surgical hubmodular enclosure 136 is enabling the quick removal and/or replacementof various modules.

Aspects of the present disclosure present a modular surgical enclosurefor use in a surgical procedure that involves energy application totissue. The modular surgical enclosure includes a first energy-generatormodule, configured to generate a first energy for application to thetissue, and a first docking station comprising a first docking port thatincludes first data and power contacts, wherein the firstenergy-generator module is slidably movable into an electricalengagement with the power and data contacts and wherein the firstenergy-generator module is slidably movable out of the electricalengagement with the first power and data contacts.

Further to the above, the modular surgical enclosure also includes asecond energy-generator module configured to generate a second energy,different than the first energy, for application to the tissue, and asecond docking station comprising a second docking port that includessecond data and power contacts, wherein the second energy-generatormodule is slidably movable into an electrical engagement with the powerand data contacts, and wherein the second energy-generator module isslidably movable out of the electrical engagement with the second powerand data contacts.

In addition, the modular surgical enclosure also includes acommunication bus between the first docking port and the second dockingport, configured to facilitate communication between the firstenergy-generator module and the second energy-generator module.

Referring to FIGS. 3-7, aspects of the present disclosure are presentedfor a surgical hub modular enclosure 136 that allows the modularintegration of a generator module 140, a smoke evacuation module 126,and a suction/irrigation module 128. Surgical hub modular enclosure 136further facilitates interactive communication between the modules 140,126, 128. As illustrated in FIG. 5, the generator module 140 can be agenerator module with integrated monopolar, bipolar, and ultrasoniccomponents supported in a single housing unit 139 slidably insertableinto surgical hub modular enclosure 136. As illustrated in FIG. 5, thegenerator module 140 can be configured to connect to a monopolar device146, a bipolar device 147, and an ultrasonic device 148. Alternatively,the generator module 140 may comprise a series of monopolar, bipolar,and/or ultrasonic generator modules that interact through surgical hubmodular enclosure 136. Surgical hub modular enclosure 136 can beconfigured to facilitate the insertion of multiple generators andinteractive communication between the generators docked into surgicalhub modular enclosure 136 so that the generators would act as a singlegenerator.

In one aspect, surgical hub modular enclosure 136 comprises a modularpower and communication backplane 149 with external and wirelesscommunication headers to enable the removable attachment of the modules140, 126, 128 and interactive communication therebetween.

In one aspect, surgical hub modular enclosure 136 includes dockingstations, or drawers, 151, herein also referred to as drawers, which areconfigured to slidably receive the modules 140, 126, 128. FIG. 4illustrates a partial perspective view of a surgical hub enclosure 136,and a combo generator module 145 slidably receivable in a dockingstation 151 of the surgical hub enclosure 136. A docking port 152 withpower and data contacts on a rear side of the combo generator module 145is configured to engage a corresponding docking port 150 with power anddata contacts of a corresponding docking station 151 of surgical hubmodular enclosure 136 as the combo generator module 145 is slid intoposition within the corresponding docking station 151 of surgical hubmodule enclosure 136. In one aspect, the combo generator module 145includes a bipolar, ultrasonic, and monopolar module and a smokeevacuation module integrated together into a single housing unit 139, asillustrated in FIG. 5.

In various aspects, the smoke evacuation module 126 includes a fluidline 154 that conveys captured/collected smoke and/or fluid away from asurgical site and to, for example, the smoke evacuation module 126.Vacuum suction originating from the smoke evacuation module 126 can drawthe smoke into an opening of a utility conduit at the surgical site. Theutility conduit, coupled to the fluid line, can be in the form of aflexible tube terminating at the smoke evacuation module 126. Theutility conduit and the fluid line define a fluid path extending towardthe smoke evacuation module 126 that is received in surgical hubenclosure 136.

In various aspects, the suction/irrigation module 128 is coupled to asurgical tool comprising an aspiration fluid line and a suction fluidline. In one example, the aspiration and suction fluid lines are in theform of flexible tubes extending from the surgical site toward thesuction/irrigation module 128. One or more drive systems can beconfigured to cause irrigation and aspiration of fluids to and from thesurgical site.

In one aspect, the surgical tool includes a shaft having an end effectorat a distal end thereof and at least one energy treatment associatedwith the end effector, an aspiration tube, and an irrigation tube. Theaspiration tube can have an inlet port at a distal end thereof and theaspiration tube extends through the shaft. Similarly, an irrigation tubecan extend through the shaft and can have an inlet port in proximity tothe energy deliver implement. The energy deliver implement is configuredto deliver ultrasonic and/or RF energy to the surgical site and iscoupled to the generator module 140 by a cable extending initiallythrough the shaft.

The irrigation tube can be in fluid communication with a fluid source,and the aspiration tube can be in fluid communication with a vacuumsource. The fluid source and/or the vacuum source can be housed in thesuction/irrigation module 128. In one example, the fluid source and/orthe vacuum source can be housed in surgical hub enclosure 136 separatelyfrom the suction/irrigation module 128. In such example, a fluidinterface can be configured to connect the suction/irrigation module 128to the fluid source and/or the vacuum source.

In one aspect, the modules 140, 126, 128 and/or their correspondingdocking stations on surgical hub modular enclosure 136 may includealignment features that are configured to align the docking ports of themodules into engagement with their counterparts in the docking stationsof surgical hub modular enclosure 136. For example, as illustrated inFIG. 4, the combo generator module 145 includes side brackets 155 thatare configured to slidably engage with corresponding brackets 156 of thecorresponding docking station 151 of surgical hub modular enclosure 136.The brackets cooperate to guide the docking port contacts of the combogenerator module 145 into an electrical engagement with the docking portcontacts of surgical hub modular enclosure 136.

In some aspects, the drawers 151 of surgical hub modular enclosure 136are the same, or substantially the same size, and the modules areadjusted in size to be received in the drawers 151. For example, theside brackets 155 and/or 156 can be larger or smaller depending on thesize of the module. In other aspects, the drawers 151 are different insize and are each designed to accommodate a particular module.

Furthermore, the contacts of a particular module can be keyed forengagement with the contacts of a particular drawer to avoid inserting amodule into a drawer with mismatching contacts.

As illustrated in FIG. 4, the docking port 150 of one drawer 151 can becoupled to the docking port 150 of another drawer 151 through acommunications link 157 to facilitate an interactive communicationbetween the modules housed in surgical hub modular enclosure 136. Thedocking ports 150 of surgical hub modular enclosure 136 mayalternatively, or additionally, facilitate a wireless interactivecommunication between the modules housed in surgical hub modularenclosure 136. Any suitable wireless communication can be employed, suchas for example Air Titan-Bluetooth.

FIG. 6 illustrates individual power bus attachments for a plurality oflateral docking ports of a lateral modular housing 160 configured toreceive a plurality of modules of a surgical hub 206. The lateralmodular housing 160 is configured to laterally receive and interconnectthe modules 161. The modules 161 are slidably inserted into dockingstations 162 of lateral modular housing 160, which includes a backplanefor interconnecting the modules 161. As illustrated in FIG. 6, themodules 161 are arranged laterally in the lateral modular housing 160.Alternatively, the modules 161 may be arranged vertically in a lateralmodular housing.

FIG. 7 illustrates a vertical modular housing 164 configured to receivea plurality of modules 165 of the surgical hub 106. The modules 165 areslidably inserted into docking stations, or drawers, 167 of verticalmodular housing 164, which includes a backplane for interconnecting themodules 165. Although the drawers 167 of the vertical modular housing164 are arranged vertically, in certain instances, a vertical modularhousing 164 may include drawers that are arranged laterally.Furthermore, the modules 165 may interact with one another through thedocking ports of the vertical modular housing 164. In the example ofFIG. 7, a display 177 is provided for displaying data relevant to theoperation of the modules 165. In addition, the vertical modular housing164 includes a master module 178 housing a plurality of sub-modules thatare slidably received in the master module 178.

In various aspects, the imaging module 138 comprises an integrated videoprocessor and a modular light source and is adapted for use with variousimaging devices. In one aspect, the imaging device is comprised of amodular housing that can be assembled with a light source module and acamera module. The housing can be a disposable housing. In at least oneexample, the disposable housing is removably coupled to a reusablecontroller, a light source module, and a camera module. The light sourcemodule and/or the camera module can be selectively chosen depending onthe type of surgical procedure. In one aspect, the camera modulecomprises a CCD sensor. In another aspect, the camera module comprises aCMOS sensor. In another aspect, the camera module is configured forscanned beam imaging. Likewise, the light source module can beconfigured to deliver a white light or a different light, depending onthe surgical procedure.

During a surgical procedure, removing a surgical device from thesurgical field and replacing it with another surgical device thatincludes a different camera or a different light source can beinefficient. Temporarily losing sight of the surgical field may lead toundesirable consequences. The module imaging device of the presentdisclosure is configured to permit the replacement of a light sourcemodule or a camera module midstream during a surgical procedure, withouthaving to remove the imaging device from the surgical field.

In one aspect, the imaging device comprises a tubular housing thatincludes a plurality of channels. A first channel is configured toslidably receive the camera module, which can be configured for asnap-fit engagement with the first channel. A second channel isconfigured to slidably receive the light source module, which can beconfigured for a snap-fit engagement with the second channel. In anotherexample, the camera module and/or the light source module can be rotatedinto a final position within their respective channels. A threadedengagement can be employed in lieu of the snap-fit engagement.

In various examples, multiple imaging devices are placed at differentpositions in the surgical field to provide multiple views. The imagingmodule 138 can be configured to switch between the imaging devices toprovide an optimal view. In various aspects, the imaging module 138 canbe configured to integrate the images from the different imaging device.

Various image processors and imaging devices suitable for use with thepresent disclosure are described in U.S. Pat. No. 7,995,045, titledCOMBINED SBI AND CONVENTIONAL IMAGE PROCESSOR, which issued on Aug. 9,2011, which is herein incorporated by reference in its entirety. Inaddition, U.S. Pat. No. 7,982,776, titled SBI MOTION ARTIFACT REMOVALAPPARATUS AND METHOD, which issued on Jul. 19, 2011, which is hereinincorporated by reference in its entirety, describes various systems forremoving motion artifacts from image data. Such systems can beintegrated with the imaging module 138. Furthermore, U.S. PatentApplication Publication No. 2011/0306840, titled CONTROLLABLE MAGNETICSOURCE TO FIXTURE INTRACORPOREAL APPARATUS, which published on Dec. 15,2011, and U.S. Patent Application Publication No. 2014/0243597, titledSYSTEM FOR PERFORMING A MINIMALLY INVASIVE SURGICAL PROCEDURE, whichpublished on Aug. 28, 2014, the disclosure of each of which is hereinincorporated by reference in its entirety.

FIG. 8 illustrates a surgical data network 201 comprising a modularcommunication hub 203 configured to connect modular devices located inone or more operating theaters of a healthcare facility, or any room ina healthcare facility specially equipped for surgical operations, to acloud-based system (e.g., the cloud 204 that may include a remote server213 coupled to a storage device 205). In one aspect, the modularcommunication hub 203 comprises a network hub 207 and/or a networkswitch 209 in communication with a network router. The modularcommunication hub 203 also can be coupled to a local computer system 210to provide local computer processing and data manipulation. The surgicaldata network 201 may be configured as passive, intelligent, orswitching. A passive surgical data network serves as a conduit for thedata, enabling it to go from one device (or segment) to another and tothe cloud computing resources. An intelligent surgical data networkincludes additional features to enable the traffic passing through thesurgical data network to be monitored and to configure each port in thenetwork hub 207 or network switch 209. An intelligent surgical datanetwork may be referred to as a manageable hub or switch. A switchinghub reads the destination address of each packet and then forwards thepacket to the correct port.

Modular devices 1 a-1 n located in the operating theater may be coupledto the modular communication hub 203. The network hub 207 and/or thenetwork switch 209 may be coupled to a network router 211 to connect thedevices 1 a-1 n to the cloud 204 or the local computer system 210. Dataassociated with the devices 1 a-1 n may be transferred to cloud-basedcomputers via the router for remote data processing and manipulation.Data associated with the devices 1 a-1 n may also be transferred to thelocal computer system 210 for local data processing and manipulation.Modular devices 2 a-2 m located in the same operating theater also maybe coupled to a network switch 209. The network switch 209 may becoupled to the network hub 207 and/or the network router 211 to connectto the devices 2 a-2 m to the cloud 204. Data associated with thedevices 2 a-2 n may be transferred to the cloud 204 via the networkrouter 211 for data processing and manipulation. Data associated withthe devices 2 a-2 m may also be transferred to the local computer system210 for local data processing and manipulation.

It will be appreciated that the surgical data network 201 may beexpanded by interconnecting multiple network hubs 207 and/or multiplenetwork switches 209 with multiple network routers 211. The modularcommunication hub 203 may be contained in a modular control towerconfigured to receive multiple devices 1 a-1 n/ 2 a-2 m. The localcomputer system 210 also may be contained in a modular control tower.The modular communication hub 203 is connected to a display 212 todisplay images obtained by some of the devices 1 a-1 n/ 2 a-2 m, forexample during surgical procedures. In various aspects, the devices 1a-1 n/ 2 a-2 m may include, for example, various modules such as animaging module 138 coupled to an endoscope, a generator module 140coupled to an energy-based surgical device, a smoke evacuation module126, a suction/irrigation module 128, a communication module 130, aprocessor module 132, a storage array 134, a surgical device coupled toa display, and/or a non-contact sensor module, among other modulardevices that may be connected to the modular communication hub 203 ofthe surgical data network 201.

In one aspect, the surgical data network 201 may comprise a combinationof network hub(s), network switch(es), and network router(s) connectingthe devices 1 a-1 n/ 2 a-2 m to the cloud. Any one of or all of thedevices 1 a-1 n/ 2 a-2 m coupled to the network hub or network switchmay collect data in real time and transfer the data to cloud computersfor data processing and manipulation. It will be appreciated that cloudcomputing relies on sharing computing resources rather than having localservers or personal devices to handle software applications. The word“cloud” may be used as a metaphor for “the Internet,” although the termis not limited as such. Accordingly, the term “cloud computing” may beused herein to refer to “a type of Internet-based computing,” wheredifferent services—such as servers, storage, and applications—aredelivered to the modular communication hub 203 and/or computer system210 located in the surgical theater (e.g., a fixed, mobile, temporary,or field operating room or space) and to devices connected to themodular communication hub 203 and/or computer system 210 through theInternet. The cloud infrastructure may be maintained by a cloud serviceprovider. In this context, the cloud service provider may be the entitythat coordinates the usage and control of the devices 1 a-1 n/ 2 a-2 mlocated in one or more operating theaters. The cloud computing servicescan perform a large number of calculations based on the data gathered bysmart surgical instruments, robots, and other computerized deviceslocated in the operating theater. Surgical hub hardware enables multipledevices or connections to be connected to a computer that communicateswith the cloud computing resources and storage.

Applying cloud computer data processing techniques on the data collectedby the devices 1 a-1 n/ 2 a-2 m, the surgical data network providesimproved surgical outcomes, reduced costs, and improved patientsatisfaction. At least some of the devices 1 a-1 n/ 2 a-2 m may beemployed to view tissue states to assess leaks or perfusion of sealedtissue after a tissue sealing and cutting procedure. At least some ofthe devices 1 a-1 n/ 2 a-2 m may be employed to identify pathology, suchas the effects of diseases, using the cloud-based computing to examinedata including images of samples of body tissue for diagnostic purposes.This includes localization and margin confirmation of tissue andphenotypes. At least some of the devices 1 a-1 n/ 2 a-2 m may beemployed to identify anatomical structures of the body using a varietyof sensors integrated with imaging devices and techniques such asoverlaying images captured by multiple imaging devices. The datagathered by the devices 1 a-1 n/ 2 a-2 m, including image data, may betransferred to the cloud 204 or the local computer system 210 or bothfor data processing and manipulation including image processing andmanipulation. The data may be analyzed to improve surgical procedureoutcomes by determining if further treatment, such as the application ofendoscopic intervention, emerging technologies, a targeted radiation,targeted intervention, and precise robotics to tissue-specific sites andconditions, may be pursued. Such data analysis may further employoutcome analytics processing, and using standardized approaches mayprovide beneficial feedback to either confirm surgical treatments andthe behavior of the surgeon or suggest modifications to surgicaltreatments and the behavior of the surgeon.

In one implementation, the operating theater devices 1 a-1 n may beconnected to the modular communication hub 203 over a wired channel or awireless channel depending on the configuration of the devices 1 a-1 nto a network hub. The network hub 207 may be implemented, in one aspect,as a local network broadcast device that works on the physical layer ofthe Open System Interconnection (OSI) model. The network hub providesconnectivity to the devices 1 a-1 n located in the same operatingtheater network. The network hub 207 collects data in the form ofpackets and sends them to the router in half duplex mode. The networkhub 207 does not store any media access control/internet protocol(MAC/IP) to transfer the device data. Only one of the devices 1 a-1 ncan send data at a time through the network hub 207. The network hub 207has no routing tables or intelligence regarding where to sendinformation and broadcasts all network data across each connection andto a remote server 213 (FIG. 9) over the cloud 204. The network hub 207can detect basic network errors such as collisions, but having allinformation broadcast to multiple ports can be a security risk and causebottlenecks.

In another implementation, the operating theater devices 2 a-2 m may beconnected to a network switch 209 over a wired channel or a wirelesschannel. The network switch 209 works in the data link layer of the OSImodel. The network switch 209 is a multicast device for connecting thedevices 2 a-2 m located in the same operating theater to the network.The network switch 209 sends data in the form of frames to the networkrouter 211 and works in full duplex mode. Multiple devices 2 a-2 m cansend data at the same time through the network switch 209. The networkswitch 209 stores and uses MAC addresses of the devices 2 a-2 m totransfer data.

The network hub 207 and/or the network switch 209 are coupled to thenetwork router 211 for connection to the cloud 204. The network router211 works in the network layer of the OSI model. The network router 211creates a route for transmitting data packets received from the networkhub 207 and/or network switch 211 to cloud-based computer resources forfurther processing and manipulation of the data collected by any one ofor all the devices 1 a-1 n/ 2 a-2 m. The network router 211 may beemployed to connect two or more different networks located in differentlocations, such as, for example, different operating theaters of thesame healthcare facility or different networks located in differentoperating theaters of different healthcare facilities. The networkrouter 211 sends data in the form of packets to the cloud 204 and worksin full duplex mode. Multiple devices can send data at the same time.The network router 211 uses IP addresses to transfer data.

In one example, the network hub 207 may be implemented as a USB hub,which allows multiple USB devices to be connected to a host computer.The USB hub may expand a single USB port into several tiers so thatthere are more ports available to connect devices to the host systemcomputer. The network hub 207 may include wired or wireless capabilitiesto receive information over a wired channel or a wireless channel. Inone aspect, a wireless USB short-range, high-bandwidth wireless radiocommunication protocol may be employed for communication between thedevices 1 a-1 n and devices 2 a-2 m located in the operating theater.

In other examples, the operating theater devices 1 a-1 n/ 2 a-2 m maycommunicate to the modular communication hub 203 via Bluetooth wirelesstechnology standard for exchanging data over short distances (usingshort-wavelength UHF radio waves in the ISM band from 2.4 to 2.485 GHz)from fixed and mobile devices and building personal area networks(PANs). In other aspects, the operating theater devices 1 a-1 n/ 2 a-2 mmay communicate to the modular communication hub 203 via a number ofwireless or wired communication standards or protocols, including butnot limited to Wi-Fi (IEEE 802.11 family), WiMAX (IEEE 802.16 family),IEEE 802.20, long-term evolution (LTE), and Ev-DO, HSPA+, HSDPA+,HSUPA+, EDGE, GSM, GPRS, CDMA, TDMA, DECT, and Ethernet derivativesthereof, as well as any other wireless and wired protocols that aredesignated as 3G, 4G, 5G, and beyond. The computing module may include aplurality of communication modules. For instance, a first communicationmodule may be dedicated to shorter-range wireless communications such asWi-Fi and Bluetooth, and a second communication module may be dedicatedto longer-range wireless communications such as GPS, EDGE, GPRS, CDMA,WiMAX, LTE, Ev-DO, and others.

The modular communication hub 203 may serve as a central connection forone or all of the operating theater devices 1 a-1 n/ 2 a-2 m and handlesa data type known as frames. Frames carry the data generated by thedevices 1 a-1 n/ 2 a-2 m. When a frame is received by the modularcommunication hub 203, it is amplified and transmitted to the networkrouter 211, which transfers the data to the cloud computing resources byusing a number of wireless or wired communication standards orprotocols, as described herein.

The modular communication hub 203 can be used as a standalone device orbe connected to compatible network hubs and network switches to form alarger network. The modular communication hub 203 is generally easy toinstall, configure, and maintain, making it a good option for networkingthe operating theater devices 1 a-1 n/ 2 a-2 m.

FIG. 9 illustrates a computer-implemented interactive surgical system200. The computer-implemented interactive surgical system 200 is similarin many respects to the computer-implemented interactive surgical system100. For example, the computer-implemented interactive surgical system200 includes one or more surgical systems 202, which are similar in manyrespects to the surgical systems 102. Each surgical system 202 includesat least one surgical hub 206 in communication with a cloud 204 that mayinclude a remote server 213. In one aspect, the computer-implementedinteractive surgical system 200 comprises a modular control tower 236connected to multiple operating theater devices such as, for example,intelligent surgical instruments, robots, and other computerized deviceslocated in the operating theater. As shown in FIG. 10, the modularcontrol tower 236 comprises a modular communication hub 203 coupled to acomputer system 210. As illustrated in the example of FIG. 9, themodular control tower 236 is coupled to an imaging module 238 that iscoupled to an endoscope 239, a generator module 240 that is coupled toan energy device 241, a smoke evacuation module 226, asuction/irrigation module 228, a communication module 230, a processormodule 232, a storage array 234, a smart device/instrument 235optionally coupled to a display 237, and a non-contact sensor module242. The operating theater devices are coupled to cloud computingresources and data storage via the modular control tower 236. A robothub 222 also may be connected to the modular control tower 236 and tothe cloud computing resources. The devices/instruments 235,visualization systems 208, among others, may be coupled to the modularcontrol tower 236 via wired or wireless communication standards orprotocols, as described herein. The modular control tower 236 may becoupled to a surgical hub display 215 (e.g., monitor, screen) to displayand overlay images received from the imaging module, device/instrumentdisplay, and/or other visualization systems 208. Surgical hub displayalso may display data received from devices connected to the modularcontrol tower in conjunction with images and overlaid images.

FIG. 10 illustrates a surgical hub 206 comprising a plurality of modulescoupled to the modular control tower 236. The modular control tower 236comprises a modular communication hub 203, e.g., a network connectivitydevice, and a computer system 210 to provide local processing,visualization, and imaging, for example. As shown in FIG. 10, themodular communication hub 203 may be connected in a tiered configurationto expand the number of modules (e.g., devices) that may be connected tothe modular communication hub 203 and transfer data associated with themodules to the computer system 210, cloud computing resources, or both.As shown in FIG. 10, each of the network hubs/switches in the modularcommunication hub 203 includes three downstream ports and one upstreamport. The upstream network hub/switch is connected to a processor toprovide a communication connection to the cloud computing resources anda local display 217. Communication to the cloud 204 may be made eitherthrough a wired or a wireless communication channel.

The surgical hub 206 employs a non-contact sensor module 242 to measurethe dimensions of the operating theater and generate a map of thesurgical theater using either ultrasonic or laser-type non-contactmeasurement devices. An ultrasound-based non-contact sensor module scansthe operating theater by transmitting a burst of ultrasound andreceiving the echo when it bounces off the perimeter walls of anoperating theater as described under the heading “Surgical Hub SpatialAwareness Within an Operating Room” in U.S. Provisional PatentApplication Ser. No. 62/611,341, titled INTERACTIVE SURGICAL PLATFORM,filed Dec. 28, 2017, which is herein incorporated by reference in itsentirety, in which the sensor module is configured to determine the sizeof the operating theater and to adjust Bluetooth-pairing distancelimits. A laser-based non-contact sensor module scans the operatingtheater by transmitting laser light pulses, receiving laser light pulsesthat bounce off the perimeter walls of the operating theater, andcomparing the phase of the transmitted pulse to the received pulse todetermine the size of the operating theater and to adjust Bluetoothpairing distance limits, for example.

The computer system 210 comprises a processor 244 and a networkinterface 245. The processor 244 is coupled to a communication module247, storage 248, memory 249, non-volatile memory 250, and input/outputinterface 251 via a system bus. The system bus can be any of severaltypes of bus structure(s) including the memory bus or memory controller,a peripheral bus or external bus, and/or a local bus using any varietyof available bus architectures including, but not limited to, 9-bit bus,Industrial Standard Architecture (ISA), Micro-Charmel Architecture(MSA), Extended ISA (EISA), Intelligent Drive Electronics (IDE), VESALocal Bus (VLB), Peripheral Component Interconnect (PCI), USB, AdvancedGraphics Port (AGP), Personal Computer Memory Card InternationalAssociation bus (PCMCIA), Small Computer Systems Interface (SCSI), orany other proprietary bus.

The processor 244 may be any single-core or multicore processor such asthose known under the trade name ARM Cortex by Texas Instruments. In oneaspect, the processor may be an LM4F230H5QR ARM Cortex-M4F ProcessorCore, available from Texas Instruments, for example, comprising anon-chip memory of 256 KB single-cycle flash memory, or othernon-volatile memory, up to 40 MHz, a prefetch buffer to improveperformance above 40 MHz, a 32 KB single-cycle serial random accessmemory (SRAM), an internal read-only memory (ROM) loaded withStellarisWare® software, a 2 KB electrically erasable programmableread-only memory (EEPROM), and/or one or more pulse width modulation(PWM) modules, one or more quadrature encoder inputs (QEI) analogs, oneor more 12-bit analog-to-digital converters (ADCs) with 12 analog inputchannels, details of which are available for the product datasheet.

In one aspect, the processor 244 may comprise a safety controllercomprising two controller-based families such as TMS570 and RM4x, knownunder the trade name Hercules ARM Cortex R4, also by Texas Instruments.The safety controller may be configured specifically for IEC 61508 andISO 26262 safety critical applications, among others, to provideadvanced integrated safety features while delivering scalableperformance, connectivity, and memory options.

The system memory includes volatile memory and non-volatile memory. Thebasic input/output system (BIOS), containing the basic routines totransfer information between elements within the computer system, suchas during start-up, is stored in non-volatile memory. For example, thenon-volatile memory can include ROM, programmable ROM (PROM),electrically programmable ROM (EPROM), EEPROM, or flash memory. Volatilememory includes random-access memory (RAM), which acts as external cachememory. Moreover, RAM is available in many forms such as SRAM, dynamicRAM (DRAM), synchronous DRAM (SDRAM), double data rate SDRAM (DDRSDRAM), enhanced SDRAM (ESDRAM), Synchlink DRAM (SLDRAM), and directRambus RAM (DRRAM).

The computer system 210 also includes removable/non-removable,volatile/non-volatile computer storage media, such as for example diskstorage. The disk storage includes, but is not limited to, devices likea magnetic disk drive, floppy disk drive, tape drive, Jaz drive, Zipdrive, LS-60 drive, flash memory card, or memory stick. In addition, thedisk storage can include storage media separately or in combination withother storage media including, but not limited to, an optical disc drivesuch as a compact disc ROM device (CD-ROM), compact disc recordabledrive (CD-R Drive), compact disc rewritable drive (CD-RW Drive), or adigital versatile disc ROM drive (DVD-ROM). To facilitate the connectionof the disk storage devices to the system bus, a removable ornon-removable interface may be employed.

It is to be appreciated that the computer system 210 includes softwarethat acts as an intermediary between users and the basic computerresources described in a suitable operating environment. Such softwareincludes an operating system. The operating system, which can be storedon the disk storage, acts to control and allocate resources of thecomputer system. System applications take advantage of the management ofresources by the operating system through program modules and programdata stored either in the system memory or on the disk storage. It is tobe appreciated that various components described herein can beimplemented with various operating systems or combinations of operatingsystems.

A user enters commands or information into the computer system 210through input device(s) coupled to the I/O interface 251. The inputdevices include, but are not limited to, a pointing device such as amouse, trackball, stylus, touch pad, keyboard, microphone, joystick,game pad, satellite dish, scanner, TV tuner card, digital camera,digital video camera, web camera, and the like. These and other inputdevices connect to the processor through the system bus via interfaceport(s). The interface port(s) include, for example, a serial port, aparallel port, a game port, and a USB. The output device(s) use some ofthe same types of ports as input device(s). Thus, for example, a USBport may be used to provide input to the computer system and to outputinformation from the computer system to an output device. An outputadapter is provided to illustrate that there are some output deviceslike monitors, displays, speakers, and printers, among other outputdevices that require special adapters. The output adapters include, byway of illustration and not limitation, video and sound cards thatprovide a means of connection between the output device and the systembus. It should be noted that other devices and/or systems of devices,such as remote computer(s), provide both input and output capabilities.

The computer system 210 can operate in a networked environment usinglogical connections to one or more remote computers, such as cloudcomputer(s), or local computers. The remote cloud computer(s) can be apersonal computer, server, router, network PC, workstation,microprocessor-based appliance, peer device, or other common networknode, and the like, and typically includes many or all of the elementsdescribed relative to the computer system. For purposes of brevity, onlya memory storage device is illustrated with the remote computer(s). Theremote computer(s) is logically connected to the computer system througha network interface and then physically connected via a communicationconnection. The network interface encompasses communication networkssuch as local area networks (LANs) and wide area networks (WANs). LANtechnologies include Fiber Distributed Data Interface (FDDI), CopperDistributed Data Interface (CDDI), Ethernet/IEEE 802.3, Token Ring/IEEE802.5 and the like. WAN technologies include, but are not limited to,point-to-point links, circuit-switching networks like IntegratedServices Digital Networks (ISDN) and variations thereon,packet-switching networks, and Digital Subscriber Lines (DSL).

In various aspects, the computer system 210 of FIG. 10, the imagingmodule 238 and/or visualization system 208, and/or the processor module232 of FIGS. 9-10, may comprise an image processor, image processingengine, media processor, or any specialized digital signal processor(DSP) used for the processing of digital images. The image processor mayemploy parallel computing with single instruction, multiple data (SIMD)or multiple instruction, multiple data (MIMD) technologies to increasespeed and efficiency. The digital image processing engine can perform arange of tasks. The image processor may be a system on a chip withmulticore processor architecture.

The communication connection(s) refers to the hardware/software employedto connect the network interface to the bus. While the communicationconnection is shown for illustrative clarity inside the computer system,it can also be external to the computer system 210. Thehardware/software necessary for connection to the network interfaceincludes, for illustrative purposes only, internal and externaltechnologies such as modems, including regular telephone-grade modems,cable modems, and DSL modems, ISDN adapters, and Ethernet cards.

FIG. 11 illustrates a functional block diagram of one aspect of a USBnetwork hub 300 device, according to one aspect of the presentdisclosure. In the illustrated aspect, the USB network hub device 300employs a TUSB2036 integrated circuit hub by Texas Instruments. The USBnetwork hub 300 is a CMOS device that provides an upstream USBtransceiver port 302 and up to three downstream USB transceiver ports304, 306, 308 in compliance with the USB 2.0 specification. The upstreamUSB transceiver port 302 is a differential root data port comprising adifferential data minus (DM0) input paired with a differential data plus(DP0) input. The three downstream USB transceiver ports 304, 306, 308are differential data ports where each port includes differential dataplus (DP1−DP3) outputs paired with differential data minus (DM1−DM3)outputs.

The USB network hub 300 device is implemented with a digital statemachine instead of a microcontroller, and no firmware programming isrequired. Fully compliant USB transceivers are integrated into thecircuit for the upstream USB transceiver port 302 and all downstream USBtransceiver ports 304, 306, 308. The downstream USB transceiver ports304, 306, 308 support both full-speed and low-speed devices byautomatically setting the slew rate according to the speed of the deviceattached to the ports. The USB network hub 300 device may be configuredeither in bus-powered or self-powered mode and includes a surgical hubpower logic 312 to manage power.

The USB network hub 300 device includes a serial interface engine 310(SIE). The SIE 310 is the front end of the USB network hub 300 hardwareand handles most of the protocol described in chapter 8 of the USBspecification. The SIE 310 typically comprehends signaling up to thetransaction level. The functions that it handles could include: packetrecognition, transaction sequencing, SOP, EOP, RESET, and RESUME signaldetection/generation, clock/data separation, non-return-to-zero invert(NRZI) data encoding/decoding and bit-stuffing, CRC generation andchecking (token and data), packet ID (PID) generation andchecking/decoding, and/or serial-parallel/parallel-serial conversion.The 310 receives a clock input 314 and is coupled to a suspend/resumelogic and frame timer 316 circuit and a surgical hub repeater circuit318 to control communication between the upstream USB transceiver port302 and the downstream USB transceiver ports 304, 306, 308 through portlogic circuits 320, 322, 324. The SIE 310 is coupled to a commanddecoder 326 via interface logic to control commands from a serial EEPROMvia a serial EEPROM interface 330.

In various aspects, the USB network hub 300 can connect 127 functionsconfigured in up to six logical layers (tiers) to a single computer.Further, the USB network hub 300 can connect to all peripherals using astandardized four-wire cable that provides both communication and powerdistribution. The power configurations are bus-powered and self-poweredmodes. The USB network hub 300 may be configured to support four modesof power management: a bus-powered hub, with either individual-portpower management or ganged-port power management, and the self-poweredhub, with either individual-port power management or ganged-port powermanagement. In one aspect, using a USB cable, the USB network hub 300,the upstream USB transceiver port 302 is plugged into a USB hostcontroller, and the downstream USB transceiver ports 304, 306, 308 areexposed for connecting USB compatible devices, and so forth.

FIG. 12 illustrates a logic diagram of a control system 470 of asurgical instrument or tool in accordance with one or more aspects ofthe present disclosure. The system 470 comprises a control circuit. Thecontrol circuit includes a microcontroller 461 comprising a processor462 and a memory 468. One or more of sensors 472, 474, 476, for example,provide real-time feedback to the processor 462. A motor 482, driven bya motor driver 492, operably couples a longitudinally movabledisplacement member to drive the I-beam knife element. A tracking system480 is configured to determine the position of the longitudinallymovable displacement member. The position information is provided to theprocessor 462, which can be programmed or configured to determine theposition of the longitudinally movable drive member as well as theposition of a firing member, firing bar, and I-beam knife element.Additional motors may be provided at the tool driver interface tocontrol I-beam firing, closure tube travel, shaft rotation, andarticulation. A display 473 displays a variety of operating conditionsof the instruments and may include touch screen functionality for datainput. Information displayed on the display 473 may be overlaid withimages acquired via endoscopic imaging modules.

In one aspect, the microcontroller 461 may be any single-core ormulticore processor such as those known under the trade name ARM Cortexby Texas Instruments. In one aspect, the main microcontroller 461 may bean LM4F230H5QR ARM Cortex-M4F Processor Core, available from TexasInstruments, for example, comprising an on-chip memory of 256 KBsingle-cycle flash memory, or other non-volatile memory, up to 40 MHz, aprefetch buffer to improve performance above 40 MHz, a 32 KBsingle-cycle SRAM, and internal ROM loaded with StellarisWare® software,a 2 KB EEPROM, one or more PWM modules, one or more QEI analogs, and/orone or more 12-bit ADCs with 12 analog input channels, details of whichare available for the product datasheet.

In one aspect, the microcontroller 461 may comprise a safety controllercomprising two controller-based families such as TMS570 and RM4x, knownunder the trade name Hercules ARM Cortex R4, also by Texas Instruments.The safety controller may be configured specifically for IEC 61508 andISO 26262 safety critical applications, among others, to provideadvanced integrated safety features while delivering scalableperformance, connectivity, and memory options.

The microcontroller 461 may be programmed to perform various functionssuch as precise control over the speed and position of the knife andarticulation systems. In one aspect, the microcontroller 461 includes aprocessor 462 and a memory 468. The electric motor 482 may be a brusheddirect current (DC) motor with a gearbox and mechanical links to anarticulation or knife system. In one aspect, a motor driver 492 may bean A3941 available from Allegro Microsystems, Inc. Other motor driversmay be readily substituted for use in the tracking system 480 comprisingan absolute positioning system. A detailed description of an absolutepositioning system is described in U.S. Patent Application PublicationNo. 2017/0296213, titled SYSTEMS AND METHODS FOR CONTROLLING A SURGICALSTAPLING AND CUTTING INSTRUMENT, which published on Oct. 19, 2017, whichis herein incorporated by reference in its entirety.

The microcontroller 461 may be programmed to provide precise controlover the speed and position of displacement members and articulationsystems. The microcontroller 461 may be configured to compute a responsein the software of the microcontroller 461. The computed response iscompared to a measured response of the actual system to obtain an“observed” response, which is used for actual feedback decisions. Theobserved response is a favorable, tuned value that balances the smooth,continuous nature of the simulated response with the measured response,which can detect outside influences on the system.

In one aspect, the motor 482 may be controlled by the motor driver 492and can be employed by the firing system of the surgical instrument ortool. In various forms, the motor 482 may be a brushed DC driving motorhaving a maximum rotational speed of approximately 25,000 RPM. In otherarrangements, the motor 482 may include a brushless motor, a cordlessmotor, a synchronous motor, a stepper motor, or any other suitableelectric motor. The motor driver 492 may comprise an H-bridge drivercomprising field-effect transistors (FETs), for example. The motor 482can be powered by a power assembly releasably mounted to the handleassembly or tool housing for supplying control power to the surgicalinstrument or tool. The power assembly may comprise a battery which mayinclude a number of battery cells connected in series that can be usedas the power source to power the surgical instrument or tool. In certaincircumstances, the battery cells of the power assembly may bereplaceable and/or rechargeable. In at least one example, the batterycells can be lithium-ion batteries which can be couplable to andseparable from the power assembly.

The motor driver 492 may be an A3941 available from AllegroMicrosystems, Inc. The A3941 492 is a full-bridge controller for usewith external N-channel power metal-oxide semiconductor field-effecttransistors (MOSFETs) specifically designed for inductive loads, such asbrush DC motors. The driver 492 comprises a unique charge pump regulatorthat provides full (>10 V) gate drive for battery voltages down to 7 Vand allows the A3941 to operate with a reduced gate drive, down to 5.5V. A bootstrap capacitor may be employed to provide the above batterysupply voltage required for N-channel MOSFETs. An internal charge pumpfor the high-side drive allows DC (100% duty cycle) operation. The fullbridge can be driven in fast or slow decay modes using diode orsynchronous rectification. In the slow decay mode, current recirculationcan be through the high-side or the lowside FETs. The power FETs areprotected from shoot-through by resistor-adjustable dead time.Integrated diagnostics provide indications of undervoltage,overtemperature, and power bridge faults and can be configured toprotect the power MOSFETs under most short circuit conditions. Othermotor drivers may be readily substituted for use in the tracking system480 comprising an absolute positioning system.

The tracking system 480 comprises a controlled motor drive circuitarrangement comprising a position sensor 472 according to one aspect ofthis disclosure. The position sensor 472 for an absolute positioningsystem provides a unique position signal corresponding to the locationof a displacement member. In one aspect, the displacement memberrepresents a longitudinally movable drive member comprising a rack ofdrive teeth for meshing engagement with a corresponding drive gear of agear reducer assembly. In other aspects, the displacement memberrepresents the firing member, which could be adapted and configured toinclude a rack of drive teeth. In yet another aspect, the displacementmember represents a firing bar or the I-beam, each of which can beadapted and configured to include a rack of drive teeth. Accordingly, asused herein, the term displacement member is used generically to referto any movable member of the surgical instrument or tool such as thedrive member, the firing member, the firing bar, the I-beam, or anyelement that can be displaced. In one aspect, the longitudinally movabledrive member is coupled to the firing member, the firing bar, and theI-beam. Accordingly, the absolute positioning system can, in effect,track the linear displacement of the I-beam by tracking the lineardisplacement of the longitudinally movable drive member. In variousother aspects, the displacement member may be coupled to any positionsensor 472 suitable for measuring linear displacement. Thus, thelongitudinally movable drive member, the firing member, the firing bar,or the I-beam, or combinations thereof, may be coupled to any suitablelinear displacement sensor. Linear displacement sensors may includecontact or non-contact displacement sensors. Linear displacement sensorsmay comprise linear variable differential transformers (LVDT),differential variable reluctance transducers (DVRT), a slidepotentiometer, a magnetic sensing system comprising a movable magnet anda series of linearly arranged Hall effect sensors, a magnetic sensingsystem comprising a fixed magnet and a series of movable, linearlyarranged Hall effect sensors, an optical sensing system comprising amovable light source and a series of linearly arranged photo diodes orphoto detectors, an optical sensing system comprising a fixed lightsource and a series of movable linearly, arranged photo diodes or photodetectors, or any combination thereof.

The electric motor 482 can include a rotatable shaft that operablyinterfaces with a gear assembly that is mounted in meshing engagementwith a set, or rack, of drive teeth on the displacement member. A sensorelement may be operably coupled to a gear assembly such that a singlerevolution of the position sensor 472 element corresponds to some linearlongitudinal translation of the displacement member. An arrangement ofgearing and sensors can be connected to the linear actuator, via a rackand pinion arrangement, or a rotary actuator, via a spur gear or otherconnection. A power source supplies power to the absolute positioningsystem and an output indicator may display the output of the absolutepositioning system. The displacement member represents thelongitudinally movable drive member comprising a rack of drive teethformed thereon for meshing engagement with a corresponding drive gear ofthe gear reducer assembly. The displacement member represents thelongitudinally movable firing member, firing bar, I-beam, orcombinations thereof.

A single revolution of the sensor element associated with the positionsensor 472 is equivalent to a longitudinal linear displacement d1 of theof the displacement member, where d1 is the longitudinal linear distancethat the displacement member moves from point “a” to point “b” after asingle revolution of the sensor element coupled to the displacementmember. The sensor arrangement may be connected via a gear reductionthat results in the position sensor 472 completing one or morerevolutions for the full stroke of the displacement member. The positionsensor 472 may complete multiple revolutions for the full stroke of thedisplacement member.

A series of switches, where n is an integer greater than one, may beemployed alone or in combination with a gear reduction to provide aunique position signal for more than one revolution of the positionsensor 472. The state of the switches are fed back to themicrocontroller 461 that applies logic to determine a unique positionsignal corresponding to the longitudinal linear displacement d1+d2+ . .. dn of the displacement member. The output of the position sensor 472is provided to the microcontroller 461. The position sensor 472 of thesensor arrangement may comprise a magnetic sensor, an analog rotarysensor like a potentiometer, or an array of analog Hall-effect elements,which output a unique combination of position signals or values.

The position sensor 472 may comprise any number of magnetic sensingelements, such as, for example, magnetic sensors classified according towhether they measure the total magnetic field or the vector componentsof the magnetic field. The techniques used to produce both types ofmagnetic sensors encompass many aspects of physics and electronics. Thetechnologies used for magnetic field sensing include search coil,fluxgate, optically pumped, nuclear precession, SQUID, Hall-effect,anisotropic magnetoresistance, giant magnetoresistance, magnetic tunneljunctions, giant magnetoimpedance, magnetostrictive/piezoelectriccomposites, magnetodiode, magnetotransistor, fiber-optic, magneto-optic,and microelectromechanical systems-based magnetic sensors, among others.

In one aspect, the position sensor 472 for the tracking system 480comprising an absolute positioning system comprises a magnetic rotaryabsolute positioning system. The position sensor 472 may be implementedas an AS5055EQFT single-chip magnetic rotary position sensor availablefrom Austria Microsystems, AG. The position sensor 472 is interfacedwith the microcontroller 461 to provide an absolute positioning system.The position sensor 472 is a low-voltage and low-power component andincludes four Hall-effect elements in an area of the position sensor 472that is located above a magnet. A high-resolution ADC and a smart powermanagement controller are also provided on the chip. A coordinaterotation digital computer (CORDIC) processor, also known as thedigit-by-digit method and Volder's algorithm, is provided to implement asimple and efficient algorithm to calculate hyperbolic and trigonometricfunctions that require only addition, subtraction, bitshift, and tablelookup operations. The angle position, alarm bits, and magnetic fieldinformation are transmitted over a standard serial communicationinterface, such as a serial peripheral interface (SPI) interface, to themicrocontroller 461. The position sensor 472 provides 12 or 14 bits ofresolution. The position sensor 472 may be an AS5055 chip provided in asmall QFN 16-pin 4×4×0.85 mm package.

The tracking system 480 comprising an absolute positioning system maycomprise and/or be programmed to implement a feedback controller, suchas a PID, state feedback, and adaptive controller. A power sourceconverts the signal from the feedback controller into a physical inputto the system: in this case the voltage. Other examples include a PWM ofthe voltage, current, and force. Other sensor(s) may be provided tomeasure physical parameters of the physical system in addition to theposition measured by the position sensor 472. In some aspects, the othersensor(s) can include sensor arrangements such as those described inU.S. Pat. No. 9,345,481, titled STAPLE CARTRIDGE TISSUE THICKNESS SENSORSYSTEM, which issued on May 24, 2016, which is herein incorporated byreference in its entirety; U.S. Patent Application Publication No.2014/0263552, titled STAPLE CARTRIDGE TISSUE THICKNESS SENSOR SYSTEM,which published on Sep. 18, 2014, which is herein incorporated byreference in its entirety; and U.S. patent application Ser. No.15/628,175, titled TECHNIQUES FOR ADAPTIVE CONTROL OF MOTOR VELOCITY OFA SURGICAL STAPLING AND CUTTING INSTRUMENT, filed Jun. 20, 2017, whichis herein incorporated by reference in its entirety. In a digital signalprocessing system, an absolute positioning system is coupled to adigital data acquisition system where the output of the absolutepositioning system will have a finite resolution and sampling frequency.The absolute positioning system may comprise a compare-and-combinecircuit to combine a computed response with a measured response usingalgorithms, such as a weighted average and a theoretical control loop,that drive the computed response towards the measured response. Thecomputed response of the physical system takes into account propertieslike mass, inertial, viscous friction, inductance resistance, etc., topredict what the states and outputs of the physical system will be byknowing the input.

The absolute positioning system provides an absolute position of thedisplacement member upon power-up of the instrument, without retractingor advancing the displacement member to a reset (zero or home) positionas may be required with conventional rotary encoders that merely countthe number of steps forwards or backwards that the motor 482 has takento infer the position of a device actuator, drive bar, knife, or thelike.

A sensor 474, such as, for example, a strain gauge or a micro-straingauge, is configured to measure one or more parameters of the endeffector, such as, for example, the amplitude of the strain exerted onthe anvil during a clamping operation, which can be indicative of theclosure forces applied to the anvil. The measured strain is converted toa digital signal and provided to the processor 462. Alternatively, or inaddition to the sensor 474, a sensor 476, such as, for example, a loadsensor, can measure the closure force applied by the closure drivesystem to the anvil. The sensor 476, such as, for example, a loadsensor, can measure the firing force applied to an I-beam in a firingstroke of the surgical instrument or tool. The I-beam is configured toengage a wedge sled, which is configured to upwardly cam staple driversto force out staples into deforming contact with an anvil. The I-beamalso includes a sharpened cutting edge that can be used to sever tissueas the I-beam is advanced distally by the firing bar. Alternatively, acurrent sensor 478 can be employed to measure the current drawn by themotor 482. The force required to advance the firing member cancorrespond to the current drawn by the motor 482, for example. Themeasured force is converted to a digital signal and provided to theprocessor 462.

In one form, the strain gauge sensor 474 can be used to measure theforce applied to the tissue by the end effector. A strain gauge can becoupled to the end effector to measure the force on the tissue beingtreated by the end effector. A system for measuring forces applied tothe tissue grasped by the end effector comprises a strain gauge sensor474, such as, for example, a micro-strain gauge, that is configured tomeasure one or more parameters of the end effector, for example. In oneaspect, the strain gauge sensor 474 can measure the amplitude ormagnitude of the strain exerted on a jaw member of an end effectorduring a clamping operation, which can be indicative of the tissuecompression. The measured strain is converted to a digital signal andprovided to a processor 462 of the microcontroller 461. A load sensor476 can measure the force used to operate the knife element, forexample, to cut the tissue captured between the anvil and the staplecartridge. A magnetic field sensor can be employed to measure thethickness of the captured tissue. The measurement of the magnetic fieldsensor also may be converted to a digital signal and provided to theprocessor 462.

The measurements of the tissue compression, the tissue thickness, and/orthe force required to close the end effector on the tissue, asrespectively measured by the sensors 474, 476, can be used by themicrocontroller 461 to characterize the selected position of the firingmember and/or the corresponding value of the speed of the firing member.In one instance, a memory 468 may store a technique, an equation, and/ora lookup table which can be employed by the microcontroller 461 in theassessment.

The control system 470 of the surgical instrument or tool also maycomprise wired or wireless communication circuits to communicate withthe modular communication hub as shown in FIGS. 8-11.

FIG. 13 illustrates a control circuit 500 configured to control aspectsof the surgical instrument or tool according to one aspect of thisdisclosure. The control circuit 500 can be configured to implementvarious processes described herein. The control circuit 500 may comprisea microcontroller comprising one or more processors 502 (e.g.,microprocessor, microcontroller) coupled to at least one memory circuit504. The memory circuit 504 stores machine-executable instructions that,when executed by the processor 502, cause the processor 502 to executemachine instructions to implement various processes described herein.The processor 502 may be any one of a number of single-core or multicoreprocessors known in the art. The memory circuit 504 may comprisevolatile and non-volatile storage media. The processor 502 may includean instruction processing unit 506 and an arithmetic unit 508. Theinstruction processing unit may be configured to receive instructionsfrom the memory circuit 504 of this disclosure.

FIG. 14 illustrates a combinational logic circuit 510 configured tocontrol aspects of the surgical instrument or tool according to oneaspect of this disclosure. The combinational logic circuit 510 can beconfigured to implement various processes described herein. Thecombinational logic circuit 510 may comprise a finite state machinecomprising a combinational logic 512 configured to receive dataassociated with the surgical instrument or tool at an input 514, processthe data by the combinational logic 512, and provide an output 516.

FIG. 15 illustrates a sequential logic circuit 520 configured to controlaspects of the surgical instrument or tool according to one aspect ofthis disclosure. The sequential logic circuit 520 or the combinationallogic 522 can be configured to implement various processes describedherein. The sequential logic circuit 520 may comprise a finite statemachine. The sequential logic circuit 520 may comprise a combinationallogic 522, at least one memory circuit 524, and a clock 529, forexample. The at least one memory circuit 524 can store a current stateof the finite state machine. In certain instances, the sequential logiccircuit 520 may be synchronous or asynchronous. The combinational logic522 is configured to receive data associated with the surgicalinstrument or tool from an input 526, process the data by thecombinational logic 522, and provide an output 528. In other aspects,the circuit may comprise a combination of a processor (e.g., processor502, FIG. 13) and a finite state machine to implement various processesherein. In other aspects, the finite state machine may comprise acombination of a combinational logic circuit (e.g., combinational logiccircuit 510, FIG. 14) and the sequential logic circuit 520.

FIG. 16 illustrates a surgical instrument or tool comprising a pluralityof motors which can be activated to perform various functions. Incertain instances, a first motor can be activated to perform a firstfunction, a second motor can be activated to perform a second function,a third motor can be activated to perform a third function, a fourthmotor can be activated to perform a fourth function, and so on. Incertain instances, the plurality of motors of robotic surgicalinstrument 600 can be individually activated to cause firing, closure,and/or articulation motions in the end effector. The firing, closure,and/or articulation motions can be transmitted to the end effectorthrough a shaft assembly, for example.

In certain instances, the surgical instrument system or tool may includea firing motor 602. The firing motor 602 may be operably coupled to afiring motor drive assembly 604 which can be configured to transmitfiring motions, generated by the motor 602 to the end effector, inparticular to displace the I-beam element. In certain instances, thefiring motions generated by the motor 602 may cause the staples to bedeployed from the staple cartridge into tissue captured by the endeffector and/or the cutting edge of the I-beam element to be advanced tocut the captured tissue, for example. The I-beam element may beretracted by reversing the direction of the motor 602.

In certain instances, the surgical instrument or tool may include aclosure motor 603. The closure motor 603 may be operably coupled to aclosure motor drive assembly 605 which can be configured to transmitclosure motions, generated by the motor 603 to the end effector, inparticular to displace a closure tube to close the anvil and compresstissue between the anvil and the staple cartridge. The closure motionsmay cause the end effector to transition from an open configuration toan approximated configuration to capture tissue, for example. The endeffector may be transitioned to an open position by reversing thedirection of the motor 603.

In certain instances, the surgical instrument or tool may include one ormore articulation motors 606 a, 606 b, for example. The motors 606 a,606 b may be operably coupled to respective articulation motor driveassemblies 608 a, 608 b, which can be configured to transmitarticulation motions generated by the motors 606 a, 606 b to the endeffector. In certain instances, the articulation motions may cause theend effector to articulate relative to the shaft, for example.

As described above, the surgical instrument or tool may include aplurality of motors which may be configured to perform variousindependent functions. In certain instances, the plurality of motors ofthe surgical instrument or tool can be individually or separatelyactivated to perform one or more functions while the other motors remaininactive. For example, the articulation motors 606 a, 606 b can beactivated to cause the end effector to be articulated while the firingmotor 602 remains inactive. Alternatively, the firing motor 602 can beactivated to fire the plurality of staples, and/or to advance thecutting edge, while the articulation motor 606 remains inactive.Furthermore the closure motor 603 may be activated simultaneously withthe firing motor 602 to cause the closure tube and the I-beam element toadvance distally as described in more detail hereinbelow.

In certain instances, the surgical instrument or tool may include acommon control module 610 which can be employed with a plurality ofmotors of the surgical instrument or tool. In certain instances, thecommon control module 610 may accommodate one of the plurality of motorsat a time. For example, the common control module 610 can be couplableto and separable from the plurality of motors of the robotic surgicalinstrument individually. In certain instances, a plurality of the motorsof the surgical instrument or tool may share one or more common controlmodules such as the common control module 610. In certain instances, aplurality of motors of the surgical instrument or tool can beindividually and selectively engaged with the common control module 610.In certain instances, the common control module 610 can be selectivelyswitched from interfacing with one of a plurality of motors of thesurgical instrument or tool to interfacing with another one of theplurality of motors of the surgical instrument or tool.

In at least one example, the common control module 610 can beselectively switched between operable engagement with the articulationmotors 606 a, 606 b and operable engagement with either the firing motor602 or the closure motor 603. In at least one example, as illustrated inFIG. 16, a switch 614 can be moved or transitioned between a pluralityof positions and/or states. In a first position 616, the switch 614 mayelectrically couple the common control module 610 to the firing motor602; in a second position 617, the switch 614 may electrically couplethe common control module 610 to the closure motor 603; in a thirdposition 618 a, the switch 614 may electrically couple the commoncontrol module 610 to the first articulation motor 606 a; and in afourth position 618 b, the switch 614 may electrically couple the commoncontrol module 610 to the second articulation motor 606 b, for example.In certain instances, separate common control modules 610 can beelectrically coupled to the firing motor 602, the closure motor 603, andthe articulations motor 606 a, 606 b at the same time. In certaininstances, the switch 614 may be a mechanical switch, anelectromechanical switch, a solid-state switch, or any suitableswitching mechanism.

Each of the motors 602, 603, 606 a, 606 b may comprise a torque sensorto measure the output torque on the shaft of the motor. The force on anend effector may be sensed in any conventional manner, such as by forcesensors on the outer sides of the jaws or by a torque sensor for themotor actuating the jaws.

In various instances, as illustrated in FIG. 16, the common controlmodule 610 may comprise a motor driver 626 which may comprise one ormore H-Bridge FETs. The motor driver 626 may modulate the powertransmitted from a power source 628 to a motor coupled to the commoncontrol module 610 based on input from a microcontroller 620 (the“controller”), for example. In certain instances, the microcontroller620 can be employed to determine the current drawn by the motor, forexample, while the motor is coupled to the common control module 610, asdescribed above.

In certain instances, the microcontroller 620 may include amicroprocessor 622 (the “processor”) and one or more non-transitorycomputer-readable mediums or memory units 624 (the “memory”). In certaininstances, the memory 624 may store various program instructions, whichwhen executed may cause the processor 622 to perform a plurality offunctions and/or calculations described herein. In certain instances,one or more of the memory units 624 may be coupled to the processor 622,for example.

In certain instances, the power source 628 can be employed to supplypower to the microcontroller 620, for example. In certain instances, thepower source 628 may comprise a battery (or “battery pack” or “powerpack”), such as a lithium-ion battery, for example. In certaininstances, the battery pack may be configured to be releasably mountedto a handle for supplying power to the surgical instrument 600. A numberof battery cells connected in series may be used as the power source628. In certain instances, the power source 628 may be replaceableand/or rechargeable, for example.

In various instances, the processor 622 may control the motor driver 626to control the position, direction of rotation, and/or velocity of amotor that is coupled to the common control module 610. In certaininstances, the processor 622 can signal the motor driver 626 to stopand/or disable a motor that is coupled to the common control module 610.It should be understood that the term “processor” as used hereinincludes any suitable microprocessor, microcontroller, or other basiccomputing device that incorporates the functions of a computer's centralprocessing unit (CPU) on an integrated circuit or, at most, a fewintegrated circuits. The processor is a multipurpose, programmabledevice that accepts digital data as input, processes it according toinstructions stored in its memory, and provides results as output. It isan example of sequential digital logic, as it has internal memory.Processors operate on numbers and symbols represented in the binarynumeral system.

In one instance, the processor 622 may be any single-core or multicoreprocessor such as those known under the trade name ARM Cortex by TexasInstruments. In certain instances, the microcontroller 620 may be an LM4F230H5QR, available from Texas Instruments, for example. In at leastone example, the Texas Instruments LM4F230H5QR is an ARM Cortex-M4FProcessor Core comprising an on-chip memory of 256 KB single-cycle flashmemory, or other non-volatile memory, up to 40 MHz, a prefetch buffer toimprove performance above 40 MHz, a 32 KB single-cycle SRAM, an internalROM loaded with StellarisWare® software, a 2 KB EEPROM, one or more PWMmodules, one or more QEI analogs, one or more 12-bit ADCs with 12 analoginput channels, among other features that are readily available for theproduct datasheet. Other microcontrollers may be readily substituted foruse with the module 4410. Accordingly, the present disclosure should notbe limited in this context.

In certain instances, the memory 624 may include program instructionsfor controlling each of the motors of the surgical instrument 600 thatare couplable to the common control module 610. For example, the memory624 may include program instructions for controlling the firing motor602, the closure motor 603, and the articulation motors 606 a, 606 b.Such program instructions may cause the processor 622 to control thefiring, closure, and articulation functions in accordance with inputsfrom algorithms or control programs of the surgical instrument or tool.

In certain instances, one or more mechanisms and/or sensors such as, forexample, sensors 630 can be employed to alert the processor 622 to theprogram instructions that should be used in a particular setting. Forexample, the sensors 630 may alert the processor 622 to use the programinstructions associated with firing, closing, and articulating the endeffector. In certain instances, the sensors 630 may comprise positionsensors which can be employed to sense the position of the switch 614,for example. Accordingly, the processor 622 may use the programinstructions associated with firing the I-beam of the end effector upondetecting, through the sensors 630 for example, that the switch 614 isin the first position 616; the processor 622 may use the programinstructions associated with closing the anvil upon detecting, throughthe sensors 630 for example, that the switch 614 is in the secondposition 617; and the processor 622 may use the program instructionsassociated with articulating the end effector upon detecting, throughthe sensors 630 for example, that the switch 614 is in the third orfourth position 618 a, 618 b.

FIG. 17 is a schematic diagram of a robotic surgical instrument 700configured to operate a surgical tool described herein according to oneaspect of this disclosure. The robotic surgical instrument 700 may beprogrammed or configured to control distal/proximal translation of adisplacement member, distal/proximal displacement of a closure tube,shaft rotation, and articulation, either with single or multiplearticulation drive links. In one aspect, the surgical instrument 700 maybe programmed or configured to individually control a firing member, aclosure member, a shaft member, and/or one or more articulation members.The surgical instrument 700 comprises a control circuit 710 configuredto control motor-driven firing members, closure members, shaft members,and/or one or more articulation members.

In one aspect, the robotic surgical instrument 700 comprises a controlcircuit 710 configured to control an anvil 716 and an I-beam 714(including a sharp cutting edge) portion of an end effector 702, aremovable staple cartridge 718, a shaft 740, and one or morearticulation members 742 a, 742 b via a plurality of motors 704 a-704 e.A position sensor 734 may be configured to provide position feedback ofthe I-beam 714 to the control circuit 710. Other sensors 738 may beconfigured to provide feedback to the control circuit 710. Atimer/counter 731 provides timing and counting information to thecontrol circuit 710. An energy source 712 may be provided to operate themotors 704 a-704 e, and a current sensor 736 provides motor currentfeedback to the control circuit 710. The motors 704 a-704 e can beoperated individually by the control circuit 710 in a open-loop orclosed-loop feedback control.

In one aspect, the control circuit 710 may comprise one or moremicrocontrollers, microprocessors, or other suitable processors forexecuting instructions that cause the processor or processors to performone or more tasks. In one aspect, a timer/counter 731 provides an outputsignal, such as the elapsed time or a digital count, to the controlcircuit 710 to correlate the position of the I-beam 714 as determined bythe position sensor 734 with the output of the timer/counter 731 suchthat the control circuit 710 can determine the position of the I-beam714 at a specific time (t) relative to a starting position or the time(t) when the I-beam 714 is at a specific position relative to a startingposition. The timer/counter 731 may be configured to measure elapsedtime, count external events, or time external events.

In one aspect, the control circuit 710 may be programmed to controlfunctions of the end effector 702 based on one or more tissueconditions. The control circuit 710 may be programmed to sense tissueconditions, such as thickness, either directly or indirectly, asdescribed herein. The control circuit 710 may be programmed to select afiring control program or closure control program based on tissueconditions. A firing control program may describe the distal motion ofthe displacement member. Different firing control programs may beselected to better treat different tissue conditions. For example, whenthicker tissue is present, the control circuit 710 may be programmed totranslate the displacement member at a lower velocity and/or with lowerpower. When thinner tissue is present, the control circuit 710 may beprogrammed to translate the displacement member at a higher velocityand/or with higher power. A closure control program may control theclosure force applied to the tissue by the anvil 716. Other controlprograms control the rotation of the shaft 740 and the articulationmembers 742 a, 742 b.

In one aspect, the control circuit 710 may generate motor set pointsignals. The motor set point signals may be provided to various motorcontrollers 708 a-708 e. The motor controllers 708 a-708 e may compriseone or more circuits configured to provide motor drive signals to themotors 704 a-704 e to drive the motors 704 a-704 e as described herein.In some examples, the motors 704 a-704 e may be brushed DC electricmotors. For example, the velocity of the motors 704 a-704 e may beproportional to the respective motor drive signals. In some examples,the motors 704 a-704 e may be brushless DC electric motors, and therespective motor drive signals may comprise a PWM signal provided to oneor more stator windings of the motors 704 a-704 e. Also, in someexamples, the motor controllers 708 a-708 e may be omitted and thecontrol circuit 710 may generate the motor drive signals directly.

In one aspect, the control circuit 710 may initially operate each of themotors 704 a-704 e in an open-loop configuration for a first open-loopportion of a stroke of the displacement member. Based on the response ofthe robotic surgical instrument 700 during the open-loop portion of thestroke, the control circuit 710 may select a firing control program in aclosed-loop configuration. The response of the instrument may include atranslation distance of the displacement member during the open-loopportion, a time elapsed during the open-loop portion, the energyprovided to one of the motors 704 a-704 e during the open-loop portion,a sum of pulse widths of a motor drive signal, etc. After the open-loopportion, the control circuit 710 may implement the selected firingcontrol program for a second portion of the displacement member stroke.For example, during a closed-loop portion of the stroke, the controlcircuit 710 may modulate one of the motors 704 a-704 e based ontranslation data describing a position of the displacement member in aclosed-loop manner to translate the displacement member at a constantvelocity.

In one aspect, the motors 704 a-704 e may receive power from an energysource 712. The energy source 712 may be a DC power supply driven by amain alternating current power source, a battery, a super capacitor, orany other suitable energy source. The motors 704 a-704 e may bemechanically coupled to individual movable mechanical elements such asthe I-beam 714, anvil 716, shaft 740, articulation 742 a, andarticulation 742 b via respective transmissions 706 a-706 e. Thetransmissions 706 a-706 e may include one or more gears or other linkagecomponents to couple the motors 704 a-704 e to movable mechanicalelements. A position sensor 734 may sense a position of the I-beam 714.The position sensor 734 may be or include any type of sensor that iscapable of generating position data that indicate a position of theI-beam 714. In some examples, the position sensor 734 may include anencoder configured to provide a series of pulses to the control circuit710 as the I-beam 714 translates distally and proximally. The controlcircuit 710 may track the pulses to determine the position of the I-beam714. Other suitable position sensors may be used, including, forexample, a proximity sensor. Other types of position sensors may provideother signals indicating motion of the I-beam 714. Also, in someexamples, the position sensor 734 may be omitted. Where any of themotors 704 a-704 e is a stepper motor, the control circuit 710 may trackthe position of the I-beam 714 by aggregating the number and directionof steps that the motor 704 has been instructed to execute. The positionsensor 734 may be located in the end effector 702 or at any otherportion of the instrument. The outputs of each of the motors 704 a-704 einclude a torque sensor 744 a-744 e to sense force and have an encoderto sense rotation of the drive shaft.

In one aspect, the control circuit 710 is configured to drive a firingmember such as the I-beam 714 portion of the end effector 702. Thecontrol circuit 710 provides a motor set point to a motor control 708 a,which provides a drive signal to the motor 704 a. The output shaft ofthe motor 704 a is coupled to a torque sensor 744 a. The torque sensor744 a is coupled to a transmission 706 a which is coupled to the I-beam714. The transmission 706 a comprises movable mechanical elements suchas rotating elements and a firing member to control the movement of theI-beam 714 distally and proximally along a longitudinal axis of the endeffector 702. In one aspect, the motor 704 a may be coupled to the knifegear assembly, which includes a knife gear reduction set that includes afirst knife drive gear and a second knife drive gear. A torque sensor744 a provides a firing force feedback signal to the control circuit710. The firing force signal represents the force required to fire ordisplace the I-beam 714. A position sensor 734 may be configured toprovide the position of the I-beam 714 along the firing stroke or theposition of the firing member as a feedback signal to the controlcircuit 710. The end effector 702 may include additional sensors 738configured to provide feedback signals to the control circuit 710. Whenready to use, the control circuit 710 may provide a firing signal to themotor control 708 a. In response to the firing signal, the motor 704 amay drive the firing member distally along the longitudinal axis of theend effector 702 from a proximal stroke start position to a stroke endposition distal to the stroke start position. As the firing membertranslates distally, an I-beam 714, with a cutting element positioned ata distal end, advances distally to cut tissue located between the staplecartridge 718 and the anvil 716.

In one aspect, the control circuit 710 is configured to drive a closuremember such as the anvil 716 portion of the end effector 702. Thecontrol circuit 710 provides a motor set point to a motor control 708 b,which provides a drive signal to the motor 704 b. The output shaft ofthe motor 704 b is coupled to a torque sensor 744 b. The torque sensor744 b is coupled to a transmission 706 b which is coupled to the anvil716. The transmission 706 b comprises movable mechanical elements suchas rotating elements and a closure member to control the movement of theanvil 716 from the open and closed positions. In one aspect, the motor704 b is coupled to a closure gear assembly, which includes a closurereduction gear set that is supported in meshing engagement with theclosure spur gear. The torque sensor 744 b provides a closure forcefeedback signal to the control circuit 710. The closure force feedbacksignal represents the closure force applied to the anvil 716. Theposition sensor 734 may be configured to provide the position of theclosure member as a feedback signal to the control circuit 710.Additional sensors 738 in the end effector 702 may provide the closureforce feedback signal to the control circuit 710. The pivotable anvil716 is positioned opposite the staple cartridge 718. When ready to use,the control circuit 710 may provide a closure signal to the motorcontrol 708 b. In response to the closure signal, the motor 704 badvances a closure member to grasp tissue between the anvil 716 and thestaple cartridge 718.

In one aspect, the control circuit 710 is configured to rotate a shaftmember such as the shaft 740 to rotate the end effector 702. The controlcircuit 710 provides a motor set point to a motor control 708 c, whichprovides a drive signal to the motor 704 c. The output shaft of themotor 704 c is coupled to a torque sensor 744 c. The torque sensor 744 cis coupled to a transmission 706 c which is coupled to the shaft 740.The transmission 706 c comprises movable mechanical elements such asrotating elements to control the rotation of the shaft 740 clockwise orcounterclockwise up to and over 360°. In one aspect, the motor 704 c iscoupled to the rotational transmission assembly, which includes a tubegear segment that is formed on (or attached to) the proximal end of theproximal closure tube for operable engagement by a rotational gearassembly that is operably supported on the tool mounting plate. Thetorque sensor 744 c provides a rotation force feedback signal to thecontrol circuit 710. The rotation force feedback signal represents therotation force applied to the shaft 740. The position sensor 734 may beconfigured to provide the position of the closure member as a feedbacksignal to the control circuit 710. Additional sensors 738 such as ashaft encoder may provide the rotational position of the shaft 740 tothe control circuit 710.

In one aspect, the control circuit 710 is configured to articulate theend effector 702. The control circuit 710 provides a motor set point toa motor control 708 d, which provides a drive signal to the motor 704 d.The output shaft of the motor 704 d is coupled to a torque sensor 744 d.The torque sensor 744 d is coupled to a transmission 706 d which iscoupled to an articulation member 742 a. The transmission 706 dcomprises movable mechanical elements such as articulation elements tocontrol the articulation of the end effector 702 ±65°. In one aspect,the motor 704 d is coupled to an articulation nut, which is rotatablyjournaled on the proximal end portion of the distal spine portion and isrotatably driven thereon by an articulation gear assembly. The torquesensor 744 d provides an articulation force feedback signal to thecontrol circuit 710. The articulation force feedback signal representsthe articulation force applied to the end effector 702. Sensors 738,such as an articulation encoder, may provide the articulation positionof the end effector 702 to the control circuit 710.

In another aspect, the articulation function of the robotic surgicalsystem 700 may comprise two articulation members, or links, 742 a, 742b. These articulation members 742 a, 742 b are driven by separate diskson the robot interface (the rack) which are driven by the two motors 708d, 708 e. When the separate firing motor 704 a is provided, each ofarticulation links 742 a, 742 b can be antagonistically driven withrespect to the other link in order to provide a resistive holding motionand a load to the head when it is not moving and to provide anarticulation motion as the head is articulated. The articulation members742 a, 742 b attach to the head at a fixed radius as the head isrotated. Accordingly, the mechanical advantage of the push-and-pull linkchanges as the head is rotated. This change in the mechanical advantagemay be more pronounced with other articulation link drive systems.

In one aspect, the one or more motors 704 a-704 e may comprise a brushedDC motor with a gearbox and mechanical links to a firing member, closuremember, or articulation member. Another example includes electric motors704 a-704 e that operate the movable mechanical elements such as thedisplacement member, articulation links, closure tube, and shaft. Anoutside influence is an unmeasured, unpredictable influence of thingslike tissue, surrounding bodies, and friction on the physical system.Such outside influence can be referred to as drag, which acts inopposition to one of electric motors 704 a-704 e. The outside influence,such as drag, may cause the operation of the physical system to deviatefrom a desired operation of the physical system.

In one aspect, the position sensor 734 may be implemented as an absolutepositioning system. In one aspect, the position sensor 734 may comprisea magnetic rotary absolute positioning system implemented as anAS5055EQFT single-chip magnetic rotary position sensor available fromAustria Microsystems, AG. The position sensor 734 may interface with thecontrol circuit 710 to provide an absolute positioning system. Theposition may include multiple Hall-effect elements located above amagnet and coupled to a CORDIC processor, also known as thedigit-by-digit method and Volder's algorithm, that is provided toimplement a simple and efficient algorithm to calculate hyperbolic andtrigonometric functions that require only addition, subtraction,bitshift, and table lookup operations.

In one aspect, the control circuit 710 may be in communication with oneor more sensors 738. The sensors 738 may be positioned on the endeffector 702 and adapted to operate with the robotic surgical instrument700 to measure the various derived parameters such as the gap distanceversus time, tissue compression versus time, and anvil strain versustime. The sensors 738 may comprise a magnetic sensor, a magnetic fieldsensor, a strain gauge, a load cell, a pressure sensor, a force sensor,a torque sensor, an inductive sensor such as an eddy current sensor, aresistive sensor, a capacitive sensor, an optical sensor, and/or anyother suitable sensor for measuring one or more parameters of the endeffector 702. The sensors 738 may include one or more sensors. Thesensors 738 may be located on the staple cartridge 718 deck to determinetissue location using segmented electrodes. The torque sensors 744 a-744e may be configured to sense force such as firing force, closure force,and/or articulation force, among others. Accordingly, the controlcircuit 710 can sense (1) the closure load experienced by the distalclosure tube and its position, (2) the firing member at the rack and itsposition, (3) what portion of the staple cartridge 718 has tissue on it,and (4) the load and position on both articulation rods.

In one aspect, the one or more sensors 738 may comprise a strain gauge,such as a micro-strain gauge, configured to measure the magnitude of thestrain in the anvil 716 during a clamped condition. The strain gaugeprovides an electrical signal whose amplitude varies with the magnitudeof the strain. The sensors 738 may comprise a pressure sensor configuredto detect a pressure generated by the presence of compressed tissuebetween the anvil 716 and the staple cartridge 718. The sensors 738 maybe configured to detect impedance of a tissue section located betweenthe anvil 716 and the staple cartridge 718 that is indicative of thethickness and/or fullness of tissue located therebetween.

In one aspect, the sensors 738 may be implemented as one or more limitswitches, electromechanical devices, solid-state switches, Hall-effectdevices, magneto-resistive (MR) devices, giant magneto-resistive (GMR)devices, magnetometers, among others. In other implementations, thesensors 738 may be implemented as solid-state switches that operateunder the influence of light, such as optical sensors, IR sensors,ultraviolet sensors, among others. Still, the switches may besolid-state devices such as transistors (e.g., FET, junction FET,MOSFET, bipolar, and the like). In other implementations, the sensors738 may include electrical conductorless switches, ultrasonic switches,accelerometers, and inertial sensors, among others.

In one aspect, the sensors 738 may be configured to measure forcesexerted on the anvil 716 by the closure drive system. For example, oneor more sensors 738 can be at an interaction point between the closuretube and the anvil 716 to detect the closure forces applied by theclosure tube to the anvil 716. The forces exerted on the anvil 716 canbe representative of the tissue compression experienced by the tissuesection captured between the anvil 716 and the staple cartridge 718. Theone or more sensors 738 can be positioned at various interaction pointsalong the closure drive system to detect the closure forces applied tothe anvil 716 by the closure drive system. The one or more sensors 738may be sampled in real time during a clamping operation by the processorof the control circuit 710. The control circuit 710 receives real-timesample measurements to provide and analyze time-based information andassess, in real time, closure forces applied to the anvil 716.

In one aspect, a current sensor 736 can be employed to measure thecurrent drawn by each of the motors 704 a-704 e. The force required toadvance any of the movable mechanical elements such as the I-beam 714corresponds to the current drawn by one of the motors 704 a-704 e. Theforce is converted to a digital signal and provided to the controlcircuit 710. The control circuit 710 can be configured to simulate theresponse of the actual system of the instrument in the software of thecontroller. A displacement member can be actuated to move an I-beam 714in the end effector 702 at or near a target velocity. The roboticsurgical instrument 700 can include a feedback controller, which can beone of any feedback controllers, including, but not limited to a PID, astate feedback, a linear-quadratic (LQR), and/or an adaptive controller,for example. The robotic surgical instrument 700 can include a powersource to convert the signal from the feedback controller into aphysical input such as case voltage, PWM voltage, frequency modulatedvoltage, current, torque, and/or force, for example. Additional detailsare disclosed in U.S. patent application Ser. No. 15/636,829, titledCLOSED LOOP VELOCITY CONTROL TECHNIQUES FOR ROBOTIC SURGICAL INSTRUMENT,filed Jun. 29, 2017, which is herein incorporated by reference in itsentirety.

FIG. 18 illustrates a block diagram of a surgical instrument 750programmed to control the distal translation of a displacement memberaccording to one aspect of this disclosure. In one aspect, the surgicalinstrument 750 is programmed to control the distal translation of adisplacement member such as the I-beam 764. The surgical instrument 750comprises an end effector 752 that may comprise an anvil 766, an I-beam764 (including a sharp cutting edge), and a removable staple cartridge768.

The position, movement, displacement, and/or translation of a lineardisplacement member, such as the I-beam 764, can be measured by anabsolute positioning system, sensor arrangement, and position sensor784. Because the I-beam 764 is coupled to a longitudinally movable drivemember, the position of the I-beam 764 can be determined by measuringthe position of the longitudinally movable drive member employing theposition sensor 784. Accordingly, in the following description, theposition, displacement, and/or translation of the I-beam 764 can beachieved by the position sensor 784 as described herein. A controlcircuit 760 may be programmed to control the translation of thedisplacement member, such as the I-beam 764. The control circuit 760, insome examples, may comprise one or more microcontrollers,microprocessors, or other suitable processors for executing instructionsthat cause the processor or processors to control the displacementmember, e.g., the I-beam 764, in the manner described. In one aspect, atimer/counter 781 provides an output signal, such as the elapsed time ora digital count, to the control circuit 760 to correlate the position ofthe I-beam 764 as determined by the position sensor 784 with the outputof the timer/counter 781 such that the control circuit 760 can determinethe position of the I-beam 764 at a specific time (t) relative to astarting position. The timer/counter 781 may be configured to measureelapsed time, count external events, or time external events.

The control circuit 760 may generate a motor set point signal 772. Themotor set point signal 772 may be provided to a motor controller 758.The motor controller 758 may comprise one or more circuits configured toprovide a motor drive signal 774 to the motor 754 to drive the motor 754as described herein. In some examples, the motor 754 may be a brushed DCelectric motor. For example, the velocity of the motor 754 may beproportional to the motor drive signal 774. In some examples, the motor754 may be a brushless DC electric motor and the motor drive signal 774may comprise a PWM signal provided to one or more stator windings of themotor 754. Also, in some examples, the motor controller 758 may beomitted, and the control circuit 760 may generate the motor drive signal774 directly.

The motor 754 may receive power from an energy source 762. The energysource 762 may be or include a battery, a super capacitor, or any othersuitable energy source. The motor 754 may be mechanically coupled to theI-beam 764 via a transmission 756. The transmission 756 may include oneor more gears or other linkage components to couple the motor 754 to theI-beam 764. A position sensor 784 may sense a position of the I-beam764. The position sensor 784 may be or include any type of sensor thatis capable of generating position data that indicate a position of theI-beam 764. In some examples, the position sensor 784 may include anencoder configured to provide a series of pulses to the control circuit760 as the I-beam 764 translates distally and proximally. The controlcircuit 760 may track the pulses to determine the position of the I-beam764. Other suitable position sensors may be used, including, forexample, a proximity sensor. Other types of position sensors may provideother signals indicating motion of the I-beam 764. Also, in someexamples, the position sensor 784 may be omitted. Where the motor 754 isa stepper motor, the control circuit 760 may track the position of theI-beam 764 by aggregating the number and direction of steps that themotor 754 has been instructed to execute. The position sensor 784 may belocated in the end effector 752 or at any other portion of theinstrument.

The control circuit 760 may be in communication with one or more sensors788. The sensors 788 may be positioned on the end effector 752 andadapted to operate with the surgical instrument 750 to measure thevarious derived parameters such as gap distance versus time, tissuecompression versus time, and anvil strain versus time. The sensors 788may comprise a magnetic sensor, a magnetic field sensor, a strain gauge,a pressure sensor, a force sensor, an inductive sensor such as an eddycurrent sensor, a resistive sensor, a capacitive sensor, an opticalsensor, and/or any other suitable sensor for measuring one or moreparameters of the end effector 752. The sensors 788 may include one ormore sensors.

The one or more sensors 788 may comprise a strain gauge, such as amicro-strain gauge, configured to measure the magnitude of the strain inthe anvil 766 during a clamped condition. The strain gauge provides anelectrical signal whose amplitude varies with the magnitude of thestrain. The sensors 788 may comprise a pressure sensor configured todetect a pressure generated by the presence of compressed tissue betweenthe anvil 766 and the staple cartridge 768. The sensors 788 may beconfigured to detect impedance of a tissue section located between theanvil 766 and the staple cartridge 768 that is indicative of thethickness and/or fullness of tissue located therebetween.

The sensors 788 may be configured to measure forces exerted on the anvil766 by a closure drive system. For example, one or more sensors 788 canbe at an interaction point between a closure tube and the anvil 766 todetect the closure forces applied by a closure tube to the anvil 766.The forces exerted on the anvil 766 can be representative of the tissuecompression experienced by the tissue section captured between the anvil766 and the staple cartridge 768. The one or more sensors 788 can bepositioned at various interaction points along the closure drive systemto detect the closure forces applied to the anvil 766 by the closuredrive system. The one or more sensors 788 may be sampled in real timeduring a clamping operation by a processor of the control circuit 760.The control circuit 760 receives real-time sample measurements toprovide and analyze time-based information and assess, in real time,closure forces applied to the anvil 766.

A current sensor 786 can be employed to measure the current drawn by themotor 754. The force required to advance the I-beam 764 corresponds tothe current drawn by the motor 754. The force is converted to a digitalsignal and provided to the control circuit 760.

The control circuit 760 can be configured to simulate the response ofthe actual system of the instrument in the software of the controller. Adisplacement member can be actuated to move an I-beam 764 in the endeffector 752 at or near a target velocity. The surgical instrument 750can include a feedback controller, which can be one of any feedbackcontrollers, including, but not limited to a PID, a state feedback, LQR,and/or an adaptive controller, for example. The surgical instrument 750can include a power source to convert the signal from the feedbackcontroller into a physical input such as case voltage, PWM voltage,frequency modulated voltage, current, torque, and/or force, for example.

The actual drive system of the surgical instrument 750 is configured todrive the displacement member, cutting member, or I-beam 764, by abrushed DC motor with gearbox and mechanical links to an articulationand/or knife system. Another example is the electric motor 754 thatoperates the displacement member and the articulation driver, forexample, of an interchangeable shaft assembly. An outside influence isan unmeasured, unpredictable influence of things like tissue,surrounding bodies and friction on the physical system. Such outsideinfluence can be referred to as drag which acts in opposition to theelectric motor 754. The outside influence, such as drag, may cause theoperation of the physical system to deviate from a desired operation ofthe physical system.

Various example aspects are directed to a surgical instrument 750comprising an end effector 752 with motor-driven surgical stapling andcutting implements. For example, a motor 754 may drive a displacementmember distally and proximally along a longitudinal axis of the endeffector 752. The end effector 752 may comprise a pivotable anvil 766and, when configured for use, a staple cartridge 768 positioned oppositethe anvil 766. A clinician may grasp tissue between the anvil 766 andthe staple cartridge 768, as described herein. When ready to use theinstrument 750, the clinician may provide a firing signal, for exampleby depressing a trigger of the instrument 750. In response to the firingsignal, the motor 754 may drive the displacement member distally alongthe longitudinal axis of the end effector 752 from a proximal strokebegin position to a stroke end position distal of the stroke beginposition. As the displacement member translates distally, an I-beam 764with a cutting element positioned at a distal end, may cut the tissuebetween the staple cartridge 768 and the anvil 766.

In various examples, the surgical instrument 750 may comprise a controlcircuit 760 programmed to control the distal translation of thedisplacement member, such as the I-beam 764, for example, based on oneor more tissue conditions. The control circuit 760 may be programmed tosense tissue conditions, such as thickness, either directly orindirectly, as described herein. The control circuit 760 may beprogrammed to select a firing control program based on tissueconditions. A firing control program may describe the distal motion ofthe displacement member. Different firing control programs may beselected to better treat different tissue conditions. For example, whenthicker tissue is present, the control circuit 760 may be programmed totranslate the displacement member at a lower velocity and/or with lowerpower. When thinner tissue is present, the control circuit 760 may beprogrammed to translate the displacement member at a higher velocityand/or with higher power.

In some examples, the control circuit 760 may initially operate themotor 754 in an open loop configuration for a first open loop portion ofa stroke of the displacement member. Based on a response of theinstrument 750 during the open loop portion of the stroke, the controlcircuit 760 may select a firing control program. The response of theinstrument may include, a translation distance of the displacementmember during the open loop portion, a time elapsed during the open loopportion, energy provided to the motor 754 during the open loop portion,a sum of pulse widths of a motor drive signal, etc. After the open loopportion, the control circuit 760 may implement the selected firingcontrol program for a second portion of the displacement member stroke.For example, during the closed loop portion of the stroke, the controlcircuit 760 may modulate the motor 754 based on translation datadescribing a position of the displacement member in a closed loop mannerto translate the displacement member at a constant velocity. Additionaldetails are disclosed in U.S. patent application Ser. No. 15/720,852,titled SYSTEM AND METHODS FOR CONTROLLING A DISPLAY OF A SURGICALINSTRUMENT, filed Sep. 29, 2017, which is herein incorporated byreference in its entirety.

FIG. 19 is a schematic diagram of a surgical instrument 790 configuredto control various functions according to one aspect of this disclosure.In one aspect, the surgical instrument 790 is programmed to controldistal translation of a displacement member such as the I-beam 764. Thesurgical instrument 790 comprises an end effector 792 that may comprisean anvil 766, an I-beam 764, and a removable staple cartridge 768 whichmay be interchanged with an RF cartridge 796 (shown in dashed line).

In one aspect, sensors 788 may be implemented as a limit switch,electromechanical device, solid-state switches, Hall-effect devices, MRdevices, GMR devices, magnetometers, among others. In otherimplementations, the sensors 638 may be solid-state switches thatoperate under the influence of light, such as optical sensors, IRsensors, ultraviolet sensors, among others. Still, the switches may besolid-state devices such as transistors (e.g., FET, junction FET,MOSFET, bipolar, and the like). In other implementations, the sensors788 may include electrical conductorless switches, ultrasonic switches,accelerometers, and inertial sensors, among others.

In one aspect, the position sensor 784 may be implemented as an absolutepositioning system comprising a magnetic rotary absolute positioningsystem implemented as an AS5055EQFT single-chip magnetic rotary positionsensor available from Austria Microsystems, AG. The position sensor 784may interface with the control circuit 760 to provide an absolutepositioning system. The position may include multiple Hall-effectelements located above a magnet and coupled to a CORDIC processor, alsoknown as the digit-by-digit method and Volder's algorithm, that isprovided to implement a simple and efficient algorithm to calculatehyperbolic and trigonometric functions that require only addition,subtraction, bitshift, and table lookup operations.

In one aspect, the I-beam 764 may be implemented as a knife membercomprising a knife body that operably supports a tissue cutting bladethereon and may further include anvil engagement tabs or features andchannel engagement features or a foot. In one aspect, the staplecartridge 768 may be implemented as a standard (mechanical) surgicalfastener cartridge. In one aspect, the RF cartridge 796 may beimplemented as an RF cartridge. These and other sensors arrangements aredescribed in commonly owned U.S. patent application Ser. No. 15/628,175,titled TECHNIQUES FOR ADAPTIVE CONTROL OF MOTOR VELOCITY OF A SURGICALSTAPLING AND CUTTING INSTRUMENT, filed Jun. 20, 2017, which is hereinincorporated by reference in its entirety.

The position, movement, displacement, and/or translation of a lineardisplacement member, such as the I-beam 764, can be measured by anabsolute positioning system, sensor arrangement, and position sensorrepresented as position sensor 784. Because the I-beam 764 is coupled tothe longitudinally movable drive member, the position of the I-beam 764can be determined by measuring the position of the longitudinallymovable drive member employing the position sensor 784. Accordingly, inthe following description, the position, displacement, and/ortranslation of the I-beam 764 can be achieved by the position sensor 784as described herein. A control circuit 760 may be programmed to controlthe translation of the displacement member, such as the I-beam 764, asdescribed herein. The control circuit 760, in some examples, maycomprise one or more microcontrollers, microprocessors, or othersuitable processors for executing instructions that cause the processoror processors to control the displacement member, e.g., the I-beam 764,in the manner described. In one aspect, a timer/counter 781 provides anoutput signal, such as the elapsed time or a digital count, to thecontrol circuit 760 to correlate the position of the I-beam 764 asdetermined by the position sensor 784 with the output of thetimer/counter 781 such that the control circuit 760 can determine theposition of the I-beam 764 at a specific time (t) relative to a startingposition. The timer/counter 781 may be configured to measure elapsedtime, count external events, or time external events.

The control circuit 760 may generate a motor set point signal 772. Themotor set point signal 772 may be provided to a motor controller 758.The motor controller 758 may comprise one or more circuits configured toprovide a motor drive signal 774 to the motor 754 to drive the motor 754as described herein. In some examples, the motor 754 may be a brushed DCelectric motor. For example, the velocity of the motor 754 may beproportional to the motor drive signal 774. In some examples, the motor754 may be a brushless DC electric motor and the motor drive signal 774may comprise a PWM signal provided to one or more stator windings of themotor 754. Also, in some examples, the motor controller 758 may beomitted, and the control circuit 760 may generate the motor drive signal774 directly.

The motor 754 may receive power from an energy source 762. The energysource 762 may be or include a battery, a super capacitor, or any othersuitable energy source. The motor 754 may be mechanically coupled to theI-beam 764 via a transmission 756. The transmission 756 may include oneor more gears or other linkage components to couple the motor 754 to theI-beam 764. A position sensor 784 may sense a position of the I-beam764. The position sensor 784 may be or include any type of sensor thatis capable of generating position data that indicate a position of theI-beam 764. In some examples, the position sensor 784 may include anencoder configured to provide a series of pulses to the control circuit760 as the I-beam 764 translates distally and proximally. The controlcircuit 760 may track the pulses to determine the position of the I-beam764. Other suitable position sensors may be used, including, forexample, a proximity sensor. Other types of position sensors may provideother signals indicating motion of the I-beam 764. Also, in someexamples, the position sensor 784 may be omitted. Where the motor 754 isa stepper motor, the control circuit 760 may track the position of theI-beam 764 by aggregating the number and direction of steps that themotor has been instructed to execute. The position sensor 784 may belocated in the end effector 792 or at any other portion of theinstrument.

The control circuit 760 may be in communication with one or more sensors788. The sensors 788 may be positioned on the end effector 792 andadapted to operate with the surgical instrument 790 to measure thevarious derived parameters such as gap distance versus time, tissuecompression versus time, and anvil strain versus time. The sensors 788may comprise a magnetic sensor, a magnetic field sensor, a strain gauge,a pressure sensor, a force sensor, an inductive sensor such as an eddycurrent sensor, a resistive sensor, a capacitive sensor, an opticalsensor, and/or any other suitable sensor for measuring one or moreparameters of the end effector 792. The sensors 788 may include one ormore sensors.

The one or more sensors 788 may comprise a strain gauge, such as amicro-strain gauge, configured to measure the magnitude of the strain inthe anvil 766 during a clamped condition. The strain gauge provides anelectrical signal whose amplitude varies with the magnitude of thestrain. The sensors 788 may comprise a pressure sensor configured todetect a pressure generated by the presence of compressed tissue betweenthe anvil 766 and the staple cartridge 768. The sensors 788 may beconfigured to detect impedance of a tissue section located between theanvil 766 and the staple cartridge 768 that is indicative of thethickness and/or fullness of tissue located therebetween.

The sensors 788 may be configured to measure forces exerted on the anvil766 by the closure drive system. For example, one or more sensors 788can be at an interaction point between a closure tube and the anvil 766to detect the closure forces applied by a closure tube to the anvil 766.The forces exerted on the anvil 766 can be representative of the tissuecompression experienced by the tissue section captured between the anvil766 and the staple cartridge 768. The one or more sensors 788 can bepositioned at various interaction points along the closure drive systemto detect the closure forces applied to the anvil 766 by the closuredrive system. The one or more sensors 788 may be sampled in real timeduring a clamping operation by a processor portion of the controlcircuit 760. The control circuit 760 receives real-time samplemeasurements to provide and analyze time-based information and assess,in real time, closure forces applied to the anvil 766.

A current sensor 786 can be employed to measure the current drawn by themotor 754. The force required to advance the I-beam 764 corresponds tothe current drawn by the motor 754. The force is converted to a digitalsignal and provided to the control circuit 760.

An RF energy source 794 is coupled to the end effector 792 and isapplied to the RF cartridge 796 when the RF cartridge 796 is loaded inthe end effector 792 in place of the staple cartridge 768. The controlcircuit 760 controls the delivery of the RF energy to the RF cartridge796.

Additional details are disclosed in U.S. patent application Ser. No.15/636,096, titled SURGICAL SYSTEM COUPLABLE WITH STAPLE CARTRIDGE ANDRADIO FREQUENCY CARTRIDGE, AND METHOD OF USING SAME, filed Jun. 28,2017, which is herein incorporated by reference in its entirety.

FIG. 20 is a simplified block diagram of a generator 800 configured toprovide inductorless tuning, among other benefits. Additional details ofthe generator 800 are described in U.S. Pat. No. 9,060,775, titledSURGICAL GENERATOR FOR ULTRASONIC AND ELECTROSURGICAL DEVICES, whichissued on Jun. 23, 2015, which is herein incorporated by reference inits entirety. The generator 800 may comprise a patient isolated stage802 in communication with a non-isolated stage 804 via a powertransformer 806. A secondary winding 808 of the power transformer 806 iscontained in the isolated stage 802 and may comprise a tappedconfiguration (e.g., a center-tapped or a non-center-tappedconfiguration) to define drive signal outputs 810 a, 810 b, 810 c fordelivering drive signals to different surgical instruments, such as, forexample, an ultrasonic surgical instrument, an RF electrosurgicalinstrument, and a multifunction surgical instrument which includesultrasonic and RF energy modes that can be delivered alone orsimultaneously. In particular, drive signal outputs 810 a, 810 c mayoutput an ultrasonic drive signal (e.g., a 420V root-mean-square (RMS)drive signal) to an ultrasonic surgical instrument, and drive signaloutputs 810 b, 810 c may output an RF electrosurgical drive signal(e.g., a 100V RMS drive signal) to an RF electrosurgical instrument,with the drive signal output 810 b corresponding to the center tap ofthe power transformer 806.

In certain forms, the ultrasonic and electrosurgical drive signals maybe provided simultaneously to distinct surgical instruments and/or to asingle surgical instrument, such as the multifunction surgicalinstrument, having the capability to deliver both ultrasonic andelectrosurgical energy to tissue. It will be appreciated that theelectrosurgical signal, provided either to a dedicated electrosurgicalinstrument and/or to a combined multifunction ultrasonic/electrosurgicalinstrument may be either a therapeutic or sub-therapeutic level signalwhere the sub-therapeutic signal can be used, for example, to monitortissue or instrument conditions and provide feedback to the generator.For example, the ultrasonic and RF signals can be delivered separatelyor simultaneously from a generator with a single output port in order toprovide the desired output signal to the surgical instrument, as will bediscussed in more detail below. Accordingly, the generator can combinethe ultrasonic and electrosurgical RF energies and deliver the combinedenergies to the multifunction ultrasonic/electrosurgical instrument.Bipolar electrodes can be placed on one or both jaws of the endeffector. One jaw may be driven by ultrasonic energy in addition toelectrosurgical RF energy, working simultaneously. The ultrasonic energymay be employed to dissect tissue, while the electrosurgical RF energymay be employed for vessel sealing.

The non-isolated stage 804 may comprise a power amplifier 812 having anoutput connected to a primary winding 814 of the power transformer 806.In certain forms, the power amplifier 812 may comprise a push-pullamplifier. For example, the non-isolated stage 804 may further comprisea logic device 816 for supplying a digital output to a digital-to-analogconverter (DAC) circuit 818, which in turn supplies a correspondinganalog signal to an input of the power amplifier 812. In certain forms,the logic device 816 may comprise a programmable gate array (PGA), aFPGA, programmable logic device (PLD), among other logic circuits, forexample. The logic device 816, by virtue of controlling the input of thepower amplifier 812 via the DAC circuit 818, may therefore control anyof a number of parameters (e.g., frequency, waveform shape, waveformamplitude) of drive signals appearing at the drive signal outputs 810 a,810 b, 810 c. In certain forms and as discussed below, the logic device816, in conjunction with a processor (e.g., a DSP discussed below), mayimplement a number of DSP-based and/or other control algorithms tocontrol parameters of the drive signals output by the generator 800.

Power may be supplied to a power rail of the power amplifier 812 by aswitch-mode regulator 820, e.g., a power converter. In certain forms,the switch-mode regulator 820 may comprise an adjustable buck regulator,for example. The non-isolated stage 804 may further comprise a firstprocessor 822, which in one form may comprise a DSP processor such as anAnalog Devices ADSP-21469 SHARC DSP, available from Analog Devices,Norwood, Mass., for example, although in various forms any suitableprocessor may be employed. In certain forms the DSP processor 822 maycontrol the operation of the switch-mode regulator 820 responsive tovoltage feedback data received from the power amplifier 812 by the DSPprocessor 822 via an ADC circuit 824. In one form, for example, the DSPprocessor 822 may receive as input, via the ADC circuit 824, thewaveform envelope of a signal (e.g., an RF signal) being amplified bythe power amplifier 812. The DSP processor 822 may then control theswitch-mode regulator 820 (e.g., via a PWM output) such that the railvoltage supplied to the power amplifier 812 tracks the waveform envelopeof the amplified signal. By dynamically modulating the rail voltage ofthe power amplifier 812 based on the waveform envelope, the efficiencyof the power amplifier 812 may be significantly improved relative to afixed rail voltage amplifier schemes.

In certain forms, the logic device 816, in conjunction with the DSPprocessor 822, may implement a digital synthesis circuit such as adirect digital synthesizer control scheme to control the waveform shape,frequency, and/or amplitude of drive signals output by the generator800. In one form, for example, the logic device 816 may implement a DDScontrol algorithm by recalling waveform samples stored in a dynamicallyupdated lookup table (LUT), such as a RAM LUT, which may be embedded inan FPGA. This control algorithm is particularly useful for ultrasonicapplications in which an ultrasonic transducer, such as an ultrasonictransducer, may be driven by a clean sinusoidal current at its resonantfrequency. Because other frequencies may excite parasitic resonances,minimizing or reducing the total distortion of the motional branchcurrent may correspondingly minimize or reduce undesirable resonanceeffects. Because the waveform shape of a drive signal output by thegenerator 800 is impacted by various sources of distortion present inthe output drive circuit (e.g., the power transformer 806, the poweramplifier 812), voltage and current feedback data based on the drivesignal may be input into an algorithm, such as an error controlalgorithm implemented by the DSP processor 822, which compensates fordistortion by suitably pre-distorting or modifying the waveform samplesstored in the LUT on a dynamic, ongoing basis (e.g., in real time). Inone form, the amount or degree of pre-distortion applied to the LUTsamples may be based on the error between a computed motional branchcurrent and a desired current waveform shape, with the error beingdetermined on a sample-by-sample basis. In this way, the pre-distortedLUT samples, when processed through the drive circuit, may result in amotional branch drive signal having the desired waveform shape (e.g.,sinusoidal) for optimally driving the ultrasonic transducer. In suchforms, the LUT waveform samples will therefore not represent the desiredwaveform shape of the drive signal, but rather the waveform shape thatis required to ultimately produce the desired waveform shape of themotional branch drive signal when distortion effects are taken intoaccount.

The non-isolated stage 804 may further comprise a first ADC circuit 826and a second ADC circuit 828 coupled to the output of the powertransformer 806 via respective isolation transformers 830, 832 forrespectively sampling the voltage and current of drive signals output bythe generator 800. In certain forms, the ADC circuits 826, 828 may beconfigured to sample at high speeds (e.g., 80 mega samples per second(MSPS)) to enable oversampling of the drive signals. In one form, forexample, the sampling speed of the ADC circuits 826, 828 may enableapproximately 200× (depending on frequency) oversampling of the drivesignals. In certain forms, the sampling operations of the ADC circuit826, 828 may be performed by a single ADC circuit receiving inputvoltage and current signals via a two-way multiplexer. The use ofhigh-speed sampling in forms of the generator 800 may enable, amongother things, calculation of the complex current flowing through themotional branch (which may be used in certain forms to implementDDS-based waveform shape control described above), accurate digitalfiltering of the sampled signals, and calculation of real powerconsumption with a high degree of precision. Voltage and currentfeedback data output by the ADC circuits 826, 828 may be received andprocessed (e.g., first-in-first-out (FIFO) buffer, multiplexer) by thelogic device 816 and stored in data memory for subsequent retrieval by,for example, the DSP processor 822. As noted above, voltage and currentfeedback data may be used as input to an algorithm for pre-distorting ormodifying LUT waveform samples on a dynamic and ongoing basis. Incertain forms, this may require each stored voltage and current feedbackdata pair to be indexed based on, or otherwise associated with, acorresponding LUT sample that was output by the logic device 816 whenthe voltage and current feedback data pair was acquired. Synchronizationof the LUT samples and the voltage and current feedback data in thismanner contributes to the correct timing and stability of thepre-distortion algorithm.

In certain forms, the voltage and current feedback data may be used tocontrol the frequency and/or amplitude (e.g., current amplitude) of thedrive signals. In one form, for example, voltage and current feedbackdata may be used to determine impedance phase. The frequency of thedrive signal may then be controlled to minimize or reduce the differencebetween the determined impedance phase and an impedance phase setpoint(e.g., 0°), thereby minimizing or reducing the effects of harmonicdistortion and correspondingly enhancing impedance phase measurementaccuracy. The determination of phase impedance and a frequency controlsignal may be implemented in the DSP processor 822, for example, withthe frequency control signal being supplied as input to a DDS controlalgorithm implemented by the logic device 816.

In another form, for example, the current feedback data may be monitoredin order to maintain the current amplitude of the drive signal at acurrent amplitude setpoint. The current amplitude setpoint may bespecified directly or determined indirectly based on specified voltageamplitude and power setpoints. In certain forms, control of the currentamplitude may be implemented by control algorithm, such as, for example,a proportional-integral-derivative (PID) control algorithm, in the DSPprocessor 822. Variables controlled by the control algorithm to suitablycontrol the current amplitude of the drive signal may include, forexample, the scaling of the LUT waveform samples stored in the logicdevice 816 and/or the full-scale output voltage of the DAC circuit 818(which supplies the input to the power amplifier 812) via a DAC circuit834.

The non-isolated stage 804 may further comprise a second processor 836for providing, among other things user interface (UI) functionality. Inone form, the UI processor 836 may comprise an Atmel AT91SAM9263processor having an ARM 926EJ-S core, available from Atmel Corporation,San Jose, Calif., for example. Examples of UI functionality supported bythe UI processor 836 may include audible and visual user feedback,communication with peripheral devices (e.g., via a USB interface),communication with a foot switch, communication with an input device(e.g., a touch screen display) and communication with an output device(e.g., a speaker). The UI processor 836 may communicate with the DSPprocessor 822 and the logic device 816 (e.g., via SPI buses). Althoughthe UI processor 836 may primarily support UI functionality, it may alsocoordinate with the DSP processor 822 to implement hazard mitigation incertain forms. For example, the UI processor 836 may be programmed tomonitor various aspects of user input and/or other inputs (e.g., touchscreen inputs, foot switch inputs, temperature sensor inputs) and maydisable the drive output of the generator 800 when an erroneouscondition is detected.

In certain forms, both the DSP processor 822 and the UI processor 836,for example, may determine and monitor the operating state of thegenerator 800. For the DSP processor 822, the operating state of thegenerator 800 may dictate, for example, which control and/or diagnosticprocesses are implemented by the DSP processor 822. For the UI processor836, the operating state of the generator 800 may dictate, for example,which elements of a UI (e.g., display screens, sounds) are presented toa user. The respective DSP and UI processors 822, 836 may independentlymaintain the current operating state of the generator 800 and recognizeand evaluate possible transitions out of the current operating state.The DSP processor 822 may function as the master in this relationshipand determine when transitions between operating states are to occur.The UI processor 836 may be aware of valid transitions between operatingstates and may confirm if a particular transition is appropriate. Forexample, when the DSP processor 822 instructs the UI processor 836 totransition to a specific state, the UI processor 836 may verify thatrequested transition is valid. In the event that a requested transitionbetween states is determined to be invalid by the UI processor 836, theUI processor 836 may cause the generator 800 to enter a failure mode.

The non-isolated stage 804 may further comprise a controller 838 formonitoring input devices (e.g., a capacitive touch sensor used forturning the generator 800 on and off, a capacitive touch screen). Incertain forms, the controller 838 may comprise at least one processorand/or other controller device in communication with the UI processor836. In one form, for example, the controller 838 may comprise aprocessor (e.g., a Meg168 8-bit controller available from Atmel)configured to monitor user input provided via one or more capacitivetouch sensors. In one form, the controller 838 may comprise a touchscreen controller (e.g., a QT5480 touch screen controller available fromAtmel) to control and manage the acquisition of touch data from acapacitive touch screen.

In certain forms, when the generator 800 is in a “power off” state, thecontroller 838 may continue to receive operating power (e.g., via a linefrom a power supply of the generator 800, such as the power supply 854discussed below). In this way, the controller 838 may continue tomonitor an input device (e.g., a capacitive touch sensor located on afront panel of the generator 800) for turning the generator 800 on andoff. When the generator 800 is in the power off state, the controller838 may wake the power supply (e.g., enable operation of one or moreDC/DC voltage converters 856 of the power supply 854) if activation ofthe “on/off” input device by a user is detected. The controller 838 maytherefore initiate a sequence for transitioning the generator 800 to a“power on” state. Conversely, the controller 838 may initiate a sequencefor transitioning the generator 800 to the power off state if activationof the “on/off” input device is detected when the generator 800 is inthe power on state. In certain forms, for example, the controller 838may report activation of the “on/off” input device to the UI processor836, which in turn implements the necessary process sequence fortransitioning the generator 800 to the power off state. In such forms,the controller 838 may have no independent ability for causing theremoval of power from the generator 800 after its power on state hasbeen established.

In certain forms, the controller 838 may cause the generator 800 toprovide audible or other sensory feedback for alerting the user that apower on or power off sequence has been initiated. Such an alert may beprovided at the beginning of a power on or power off sequence and priorto the commencement of other processes associated with the sequence.

In certain forms, the isolated stage 802 may comprise an instrumentinterface circuit 840 to, for example, provide a communication interfacebetween a control circuit of a surgical instrument (e.g., a controlcircuit comprising handpiece switches) and components of thenon-isolated stage 804, such as, for example, the logic device 816, theDSP processor 822, and/or the UI processor 836. The instrument interfacecircuit 840 may exchange information with components of the non-isolatedstage 804 via a communication link that maintains a suitable degree ofelectrical isolation between the isolated and non-isolated stages 802,804, such as, for example, an IR-based communication link. Power may besupplied to the instrument interface circuit 840 using, for example, alow-dropout voltage regulator powered by an isolation transformer drivenfrom the non-isolated stage 804.

In one form, the instrument interface circuit 840 may comprise a logiccircuit 842 (e.g., logic circuit, programmable logic circuit, PGA, FPGA,PLD) in communication with a signal conditioning circuit 844. The signalconditioning circuit 844 may be configured to receive a periodic signalfrom the logic circuit 842 (e.g., a 2 kHz square wave) to generate abipolar interrogation signal having an identical frequency. Theinterrogation signal may be generated, for example, using a bipolarcurrent source fed by a differential amplifier. The interrogation signalmay be communicated to a surgical instrument control circuit (e.g., byusing a conductive pair in a cable that connects the generator 800 tothe surgical instrument) and monitored to determine a state orconfiguration of the control circuit. The control circuit may comprise anumber of switches, resistors, and/or diodes to modify one or morecharacteristics (e.g., amplitude, rectification) of the interrogationsignal such that a state or configuration of the control circuit isuniquely discernable based on the one or more characteristics. In oneform, for example, the signal conditioning circuit 844 may comprise anADC circuit for generating samples of a voltage signal appearing acrossinputs of the control circuit resulting from passage of interrogationsignal therethrough. The logic circuit 842 (or a component of thenon-isolated stage 804) may then determine the state or configuration ofthe control circuit based on the ADC circuit samples.

In one form, the instrument interface circuit 840 may comprise a firstdata circuit interface 846 to enable information exchange between thelogic circuit 842 (or other element of the instrument interface circuit840) and a first data circuit disposed in or otherwise associated with asurgical instrument. In certain forms, for example, a first data circuitmay be disposed in a cable integrally attached to a surgical instrumenthandpiece or in an adaptor for interfacing a specific surgicalinstrument type or model with the generator 800. The first data circuitmay be implemented in any suitable manner and may communicate with thegenerator according to any suitable protocol, including, for example, asdescribed herein with respect to the first data circuit. In certainforms, the first data circuit may comprise a non-volatile storagedevice, such as an EEPROM device. In certain forms, the first datacircuit interface 846 may be implemented separately from the logiccircuit 842 and comprise suitable circuitry (e.g., discrete logicdevices, a processor) to enable communication between the logic circuit842 and the first data circuit. In other forms, the first data circuitinterface 846 may be integral with the logic circuit 842.

In certain forms, the first data circuit may store informationpertaining to the particular surgical instrument with which it isassociated. Such information may include, for example, a model number, aserial number, a number of operations in which the surgical instrumenthas been used, and/or any other type of information. This informationmay be read by the instrument interface circuit 840 (e.g., by the logiccircuit 842), transferred to a component of the non-isolated stage 804(e.g., to logic device 816, DSP processor 822, and/or UI processor 836)for presentation to a user via an output device and/or for controlling afunction or operation of the generator 800. Additionally, any type ofinformation may be communicated to the first data circuit for storagetherein via the first data circuit interface 846 (e.g., using the logiccircuit 842). Such information may comprise, for example, an updatednumber of operations in which the surgical instrument has been usedand/or dates and/or times of its usage.

As discussed previously, a surgical instrument may be detachable from ahandpiece (e.g., the multifunction surgical instrument may be detachablefrom the handpiece) to promote instrument interchangeability and/ordisposability. In such cases, conventional generators may be limited intheir ability to recognize particular instrument configurations beingused and to optimize control and diagnostic processes accordingly. Theaddition of readable data circuits to surgical instruments to addressthis issue is problematic from a compatibility standpoint, however. Forexample, designing a surgical instrument to remain backwardly compatiblewith generators that lack the requisite data reading functionality maybe impractical due to, for example, differing signal schemes, designcomplexity, and cost. Forms of instruments discussed herein addressthese concerns by using data circuits that may be implemented inexisting surgical instruments economically and with minimal designchanges to preserve compatibility of the surgical instruments withcurrent generator platforms.

Additionally, forms of the generator 800 may enable communication withinstrument-based data circuits. For example, the generator 800 may beconfigured to communicate with a second data circuit contained in aninstrument (e.g., the multifunction surgical instrument). In some forms,the second data circuit may be implemented in a many similar to that ofthe first data circuit described herein. The instrument interfacecircuit 840 may comprise a second data circuit interface 848 to enablethis communication. In one form, the second data circuit interface 848may comprise a tri-state digital interface, although other interfacesmay also be used. In certain forms, the second data circuit maygenerally be any circuit for transmitting and/or receiving data. In oneform, for example, the second data circuit may store informationpertaining to the particular surgical instrument with which it isassociated. Such information may include, for example, a model number, aserial number, a number of operations in which the surgical instrumenthas been used, and/or any other type of information.

In some forms, the second data circuit may store information about theelectrical and/or ultrasonic properties of an associated ultrasonictransducer, end effector, or ultrasonic drive system. For example, thefirst data circuit may indicate a burn-in frequency slope, as describedherein. Additionally or alternatively, any type of information may becommunicated to second data circuit for storage therein via the seconddata circuit interface 848 (e.g., using the logic circuit 842). Suchinformation may comprise, for example, an updated number of operationsin which the instrument has been used and/or dates and/or times of itsusage. In certain forms, the second data circuit may transmit dataacquired by one or more sensors (e.g., an instrument-based temperaturesensor). In certain forms, the second data circuit may receive data fromthe generator 800 and provide an indication to a user (e.g., a lightemitting diode indication or other visible indication) based on thereceived data.

In certain forms, the second data circuit and the second data circuitinterface 848 may be configured such that communication between thelogic circuit 842 and the second data circuit can be effected withoutthe need to provide additional conductors for this purpose (e.g.,dedicated conductors of a cable connecting a handpiece to the generator800). In one form, for example, information may be communicated to andfrom the second data circuit using a one-wire bus communication schemeimplemented on existing cabling, such as one of the conductors usedtransmit interrogation signals from the signal conditioning circuit 844to a control circuit in a handpiece. In this way, design changes ormodifications to the surgical instrument that might otherwise benecessary are minimized or reduced. Moreover, because different types ofcommunications implemented over a common physical channel can befrequency-band separated, the presence of a second data circuit may be“invisible” to generators that do not have the requisite data readingfunctionality, thus enabling backward compatibility of the surgicalinstrument.

In certain forms, the isolated stage 802 may comprise at least oneblocking capacitor 850-1 connected to the drive signal output 810 b toprevent passage of DC current to a patient. A single blocking capacitormay be required to comply with medical regulations or standards, forexample. While failure in single-capacitor designs is relativelyuncommon, such failure may nonetheless have negative consequences. Inone form, a second blocking capacitor 850-2 may be provided in serieswith the blocking capacitor 850-1, with current leakage from a pointbetween the blocking capacitors 850-1, 850-2 being monitored by, forexample, an ADC circuit 852 for sampling a voltage induced by leakagecurrent. The samples may be received by the logic circuit 842, forexample. Based changes in the leakage current (as indicated by thevoltage samples), the generator 800 may determine when at least one ofthe blocking capacitors 850-1, 850-2 has failed, thus providing abenefit over single-capacitor designs having a single point of failure.

In certain forms, the non-isolated stage 804 may comprise a power supply854 for delivering DC power at a suitable voltage and current. The powersupply may comprise, for example, a 400 W power supply for delivering a48 VDC system voltage. The power supply 854 may further comprise one ormore DC/DC voltage converters 856 for receiving the output of the powersupply to generate DC outputs at the voltages and currents required bythe various components of the generator 800. As discussed above inconnection with the controller 838, one or more of the DC/DC voltageconverters 856 may receive an input from the controller 838 whenactivation of the “on/off” input device by a user is detected by thecontroller 838 to enable operation of, or wake, the DC/DC voltageconverters 856.

FIG. 21 illustrates an example of a generator 900, which is one form ofthe generator 800 (FIG. 20). The generator 900 is configured to delivermultiple energy modalities to a surgical instrument. The generator 900provides RF and ultrasonic signals for delivering energy to a surgicalinstrument either independently or simultaneously. The RF and ultrasonicsignals may be provided alone or in combination and may be providedsimultaneously. As noted above, at least one generator output candeliver multiple energy modalities (e.g., ultrasonic, bipolar ormonopolar RF, irreversible and/or reversible electroporation, and/ormicrowave energy, among others) through a single port, and these signalscan be delivered separately or simultaneously to the end effector totreat tissue.

The generator 900 comprises a processor 902 coupled to a waveformgenerator 904. The processor 902 and waveform generator 904 areconfigured to generate a variety of signal waveforms based oninformation stored in a memory coupled to the processor 902, not shownfor clarity of disclosure. The digital information associated with awaveform is provided to the waveform generator 904 which includes one ormore DAC circuits to convert the digital input into an analog output.The analog output is fed to an amplifier 1106 for signal conditioningand amplification. The conditioned and amplified output of the amplifier906 is coupled to a power transformer 908. The signals are coupledacross the power transformer 908 to the secondary side, which is in thepatient isolation side. A first signal of a first energy modality isprovided to the surgical instrument between the terminals labeledENERGY₁ and RETURN. A second signal of a second energy modality iscoupled across a capacitor 910 and is provided to the surgicalinstrument between the terminals labeled ENERGY₂ and RETURN. It will beappreciated that more than two energy modalities may be output and thusthe subscript “n” may be used to designate that up to n ENERGYnterminals may be provided, where n is a positive integer greater than 1.It also will be appreciated that up to “n” return paths RETURNn may beprovided without departing from the scope of the present disclosure.

A first voltage sensing circuit 912 is coupled across the terminalslabeled ENERGY₁ and the RETURN path to measure the output voltagetherebetween. A second voltage sensing circuit 924 is coupled across theterminals labeled ENERGY₂ and the RETURN path to measure the outputvoltage therebetween. A current sensing circuit 914 is disposed inseries with the RETURN leg of the secondary side of the powertransformer 908 as shown to measure the output current for either energymodality. If different return paths are provided for each energymodality, then a separate current sensing circuit should be provided ineach return leg. The outputs of the first and second voltage sensingcircuits 912, 924 are provided to respective isolation transformers 916,922 and the output of the current sensing circuit 914 is provided toanother isolation transformer 918. The outputs of the isolationtransformers 916, 928, 922 in the on the primary side of the powertransformer 908 (non-patient isolated side) are provided to a one ormore ADC circuit 926. The digitized output of the ADC circuit 926 isprovided to the processor 902 for further processing and computation.The output voltages and output current feedback information can beemployed to adjust the output voltage and current provided to thesurgical instrument and to compute output impedance, among otherparameters. Input/output communications between the processor 902 andpatient isolated circuits is provided through an interface circuit 920.Sensors also may be in electrical communication with the processor 902by way of the interface circuit 920.

In one aspect, the impedance may be determined by the processor 902 bydividing the output of either the first voltage sensing circuit 912coupled across the terminals labeled ENERGY₁/RETURN or the secondvoltage sensing circuit 924 coupled across the terminals labeledENERGY₂/RETURN by the output of the current sensing circuit 914 disposedin series with the RETURN leg of the secondary side of the powertransformer 908. The outputs of the first and second voltage sensingcircuits 912, 924 are provided to separate isolations transformers 916,922 and the output of the current sensing circuit 914 is provided toanother isolation transformer 916. The digitized voltage and currentsensing measurements from the ADC circuit 926 are provided the processor902 for computing impedance. As an example, the first energy modalityENERGY₁ may be ultrasonic energy and the second energy modality ENERGY₂may be RF energy. Nevertheless, in addition to ultrasonic and bipolar ormonopolar RF energy modalities, other energy modalities includeirreversible and/or reversible electroporation and/or microwave energy,among others. Also, although the example illustrated in FIG. 21 shows asingle return path RETURN may be provided for two or more energymodalities, in other aspects, multiple return paths RETURNn may beprovided for each energy modality ENERGYn. Thus, as described herein,the ultrasonic transducer impedance may be measured by dividing theoutput of the first voltage sensing circuit 912 by the current sensingcircuit 914 and the tissue impedance may be measured by dividing theoutput of the second voltage sensing circuit 924 by the current sensingcircuit 914.

As shown in FIG. 21, the generator 900 comprising at least one outputport can include a power transformer 908 with a single output and withmultiple taps to provide power in the form of one or more energymodalities, such as ultrasonic, bipolar or monopolar RF, irreversibleand/or reversible electroporation, and/or microwave energy, amongothers, for example, to the end effector depending on the type oftreatment of tissue being performed. For example, the generator 900 candeliver energy with higher voltage and lower current to drive anultrasonic transducer, with lower voltage and higher current to drive RFelectrodes for sealing tissue, or with a coagulation waveform for spotcoagulation using either monopolar or bipolar RF electrosurgicalelectrodes. The output waveform from the generator 900 can be steered,switched, or filtered to provide the frequency to the end effector ofthe surgical instrument. The connection of an ultrasonic transducer tothe generator 900 output would be preferably located between the outputlabeled ENERGY₁ and RETURN as shown in FIG. 21. In one example, aconnection of RF bipolar electrodes to the generator 900 output would bepreferably located between the output labeled ENERGY₂ and RETURN. In thecase of monopolar output, the preferred connections would be activeelectrode (e.g., pencil or other probe) to the ENERGY₂ output and asuitable return pad connected to the RETURN output.

Additional details are disclosed in U.S. Patent Application PublicationNo. 2017/0086914, titled TECHNIQUES FOR OPERATING GENERATOR FORDIGITALLY GENERATING ELECTRICAL SIGNAL WAVEFORMS AND SURGICALINSTRUMENTS, which published on Mar. 30, 2017, which is hereinincorporated by reference in its entirety.

FIG. 22 illustrates an electrosurgical system 60000, in accordance withat least one aspect of the present disclosure. The electrosurgicalsystem 60000 includes a generator 60002, an electrosurgical instrument60004 and a return pad 60006. The generator 60002 supplies alternatingcurrent at radiofrequency levels to the electrosurgical instrument 60004via a first conductor/cable 60008. The electrosurgical instrument 60004includes an electrode tip (i.e., an active electrode) which can bepositioned at a target tissue of a patient. The electrosurgicalinstrument 60004 receives the alternating current from the generator60002 and delivers the alternating current to the target tissue of apatient 60010 via the electrode tip. The alternating current is receivedat the target tissue, and the resistance from the tissue creates heatwhich provides the desired effect (e.g., sealing and/or cutting) at thesurgical site. The alternating current is conducted through thepatient's body and ultimately is received by the return pad 60006. Thealternating current received by the return pad 60006 is carried back tothe generator 60002 via a second conductor/cable 60012 to complete theclosed path followed by the alternating current.

According to various aspects, the generator 60002 is similar to thegenerator 900 described above, and may include, for example, a processorand a waveform generator similar to the processor 902 and the waveformgenerator 904 described above.

The electrosurgical instrument 60004 may be configured for monopolaroperation where electrosurgical energy supplied by the generator 60002is introduced into the patient's tissue by an active electrode of thesurgical instrument 60004 and is return to the generator 60002 via thereturn pad 6006. According to various aspects, the electrosurgicalinstrument 60004 includes a handpiece or pencil and an electrode tip.The electrode tip serves as the active electrode of the electrosurgicalsystem 60000 and introduces electrosurgical energy to the target tissueof a patient 60010. Specifically, an electrical discharge is deliveredfrom electrode tip to the patient 60010 in order to cause heating ofcellular matter of the patient 60010 that is in close contact with oradjacent to electrode tip. The tissue heating takes place at anappropriately high temperature to allow the electrosurgical instrument60004 to be used to perform electrosurgery.

FIG. 23 illustrates the return pad 60006 of the electrosurgical system60000 of FIG. 22, in accordance with at least one aspect of the presentdisclosure. The return pad 60006 can be similar to the MEGA SOFT®patient return electrode commercially available from Megadyne MedicalProducts, Inc. in that the return pad 60006 can include a sleeve orcovering 60014, can be separated a small distance from the patient'sbody, can be capacitively coupled with the patient's body and isconfigured to carry the amount of current introduced into the patient'sbody by the electrosurgical instrument 60004, but is different.

The return pad 60006 is different from the MEGA SOFT® patient returnelectrode commercially available from Megadyne Medical Products, Inc. inthat in lieu of one return electrode, the return pad includes aplurality of electrodes 60016 (See FIG. 24) which can be capacitivelycoupled with the patient's body and collectively are configured to carrythe amount of current introduced into the patient's body by theelectrosurgical instrument 60004. For this capacitive coupling, thepatient's body effectively acts as one plate of a capacitor andcollectively the plurality of electrodes of the return pad effectivelyact together as the other plate of the capacitor. A more detaileddescription of capacitive coupling can be found, for example, in U.S.Pat. No. 6,214,000, titled CAPACITIVE REUSABLE ELECTROSURGICAL RETURNELECTRODE, issued Apr. 10, 2001 and in U.S. Pat. No. 6,582,424, titledCAPACITIVE REUSABLE ELECTROSURGICAL RETURN ELECTRODE, issued Jun. 24,2003, the entire contents of which are each incorporated by reference.Although the return pad 60006 is shown in FIG. 23 as being substantiallyrectangular, it will be appreciated that the return pad 60006 can be ofany suitable shape.

FIG. 24 illustrates a plurality of electrodes 60016 of the return pad60006 of FIG. 23, in accordance with at least one aspect of the presentdisclosure. For purposes of clarity, the sleeve or covering 60014 of thereturn pad 60006 is not shown in FIG. 24. Although four electrodes 60016are shown in FIG. 24, it will be appreciated that the return pad 60006may include any number of electrodes 60016. For example, according tovarious aspects, the return pad 60006 includes sixteen electrodes 60016.Also, although the individual electrodes 60016 are shown in FIG. 24 asbeing substantially rectangular, it will be appreciated that theindividual electrodes can be of any suitable shape.

The electrodes 60016 of the return pad 60006 can be considered thereturn electrodes of the electrosurgical system 60000 of FIG. 22, andcan also be considered to be segmented electrodes as the electrodes60016 can be selectively decoupled from the patient's body and/or thegenerator 60002. The electrodes 60016 of the return pad 60006 can alsobe coupled together to effectively act as one large electrode. Forexample, according to various aspects, each of the electrodes 60016 ofthe return pad 60006 can be connected by respective conductive members60018 to inputs of a switching device 60020 as shown in FIG. 24. Whenthe switching device 60020 is in an open position as shown in FIG. 24,the respective electrodes 60016 of the return pad 60006 are decoupledfrom one another as well as from the patient's body and/or the generator60002. In contrast, when the switching device 60020 is in a closedposition, the respective electrodes 60016 of the return pad 60006 arecoupled together to effectively act as one large electrode.

The switching device 60020 can be controlled by a processing circuit(e.g., a processing circuit of the generator 60002 of theelectrosurgical system, a processing circuit of the surgical hub 206, aprocessing circuit of the surgical hub 106, etc.). For purposes ofsimplicity, the processing circuit is not shown in FIG. 24. According tovarious aspects, the switching device 60020 shown in FIG. 24 can beincorporated into the return pad 60006. According to other aspects, theswitching device 60006 shown in FIG. 24 can be incorporated into thesecond conductor/cable 60012 of the electrosurgical system 60000 of FIG.22. The return pad 60006 can also include a plurality of sensing devices60022 (See FIG. 25).

By being able to couple the plurality of electrodes 60016 together foruse during an electrosurgical procedure, the total effective size of theelectrodes 60016 of the return pad 60006 is large enough and/or hassufficient surface area to keep the current density sufficiently low tomitigate the likelihood of any unwanted burning of the patient 60010.

FIG. 25 illustrates an array of sensing devices 60022 of the return pad60006 of FIG. 23, in accordance with at least one aspect of the presentdisclosure. For purposes of clarity, the sleeve or covering 60014 of thereturn pad 60006 is not shown in FIG. 25. According to various aspects,the number of sensing devices 60022 corresponds to the number ofelectrodes 60016 such that there is one sensing device 60022 for eachelectrode 60016, and each sensing device 60022 is mounted to orintegrated with a corresponding electrode 60016. However, although thenumber of sensing devices 60022 shown in FIG. 25 corresponds to thenumber of electrodes 60016, it will be appreciated that the return pad60006 may include any number of sensing devices 60022. For example, foraspects of the return pad 60006 which include sixteen electrodes 60016,the return pad 60006 may only include four or eight sensing devices60022. Although the sensing devices 60022 are shown in FIG. 25 as beingcentered on the corresponding electrodes 60016, it will be appreciatedthat the sensing devices 60022 can be positioned on any portion of thecorresponding electrodes 60016 and can be positioned differently ondifferent electrodes 60016.

The sensing devices 60022 are configured to detect a monopolar nervecontrol signal applied to the patient and/or a movement of an anatomicalfeature of the patient (e.g., a muscle twitch) resulting fromapplication of the nerve control signal. The monopolar nerve controlsignal may be applied by the electrosurgical instrument 60004 of theelectrosurgical system 60000 of FIG. 22, or may be applied by adifferent surgical instrument which is coupled to a different generator.Each sensing device 60022 may include, for example, a pressure sensor,an accelerometer, combinations thereof, etc. and is configured to outputa signal indicative of the detected nerve control signal and/or thedetected movement of an anatomical feature of the patient. Such pressuresensors may include for example, piezoresistive strain gauges,capacitive pressure sensors, electromagnetic pressure sensors and/orpiezoelectric pressure sensors. Such accelerometers may include, forexample, mechanical accelerometers, capacitive accelerometers,piezoelectric accelerometers, electromagnetic accelerometers and/ormicroelectromechanical system (MEMS) accelerometers. The respectiveoutput signals of the respective sensing devices 60022 may be in theform of analog signals and/or digital signals.

Using Coulomb's law and the respective locations of the active electrodeof the electrosurgical instrument 60004, the patient's body and therespective sensing devices 60022, the respective output signals of therespected sensing devices 60022, which are indicative of a detectednerve control signal and/or movement of an anatomical feature of thepatient, can be analyzed to determine the location of a nerve within thepatient's body. Coulomb's law states that E=K(Q/r²), where E is thethreshold current required at a nerve to stimulate the nerve, K is aconstant, Q is the minimal current from the nerve stimulation electrodeand r is the distance from the nerve. The further the nerve stimulationelectrode is from the nerve, the current needed to stimulate the nerveis proportionately greater. A constant current stimulus can thus beutilized to estimate the distance from the nerve stimulation electrodeto the nerve. In general, the respective strengths of the output signalsof the respective sensing devices 60022 are indicative of how close orfar the respective sensing devices 60022 are from the stimulated nerveof the patient 60010.

According to various aspects, the analysis of the respective outputsignals of the respective sensing devices 60022 can be performed by aprocessing circuit of the generator 60002 of the electrosurgical system60000 of FIG. 22, by a processing circuit of a nerve monitoring systemwhich is separate from the generator 60002 of the electrosurgical system60000 of FIG. 22, by a processing circuit of the surgical hub 206, by aprocessing circuit of the surgical hub 106, etc. The analysis can beperformed in real time or in near-real time. According to variousaspects, the respective output signals serve as inputs to a monopolarnerve stimulation algorithm which is executed by the processing circuit.

As shown in FIG. 25, according to various aspects, the output signals ofthe respective sensing devices 60022 can be input into a multipleinput-single output switching device 60024 (e.g., a multiplexer) viarespective conductive members 60026. By controlling the selectionsignals S₀, S₁ to the multiple input-single output switching device60024, the multiple input-single output switching device 60024 can becontrolled to output only one of the output signals of the respectivesensing devices 60024 at a time for the above-described analysis. Forexample, with reference to FIG. 25, by setting the selection signals S₀,S₁ to 0,0, the output signal from the sensing device 60022 associatedwith the electrode 60016 in the upper left hand corner of FIG. 25 can beoutput by the multiple input-single output switching device 60024 foranalysis by the applicable processing circuit. By setting the selectionsignals S₀, S₁ to 0,1, the output signal from the sensing device 60022associated with the electrode 60016 in the upper right hand corner ofFIG. 25 can be output by the multiple input-single output switchingdevice 60024 for analysis by the applicable processing circuit. Bysetting the selection signals S₀, S₁ to 1,0, the output signal from thesensing device 60022 associated with the electrode 60016 in the lowerleft hand corner of FIG. 25 can be output by the multiple input-singleoutput switching device 60024 for analysis by the applicable processingcircuit. By setting the selection signals S₀, S₁ to 1,1, the outputsignal from the sensing device 60022 associated with the electrode 60016in the lower right hand corner of FIG. 25 can be output by the multipleinput-single output switching device 60024 for analysis by theapplicable processing circuit.

The selection signals S₀, S₁ can be provided to the multipleinput-single output switching device 60024 by a processing circuit suchas, for example, a processing circuit of the generator 60002 of theelectrosurgical system 60000 of FIG. 22, a processing circuit of a nervemonitoring system which is separate from the generator 60002 of theelectrosurgical system 60000 of FIG. 22, by a processing circuit of thesurgical hub 206, by a processing circuit of the surgical hub 106, etc.For purposes of simplicity, the processing circuit is not shown in FIG.25. By providing the various selection signals at a fast enough rate,the output signals of the respective sensing devices can effectively bescanned at a rate which allows for the timely analysis of all of theoutput signals of the respective sensing devices to determine theposition of the stimulated nerve.

According to various aspects, the multiple input-single output switchingdevice 60024 shown in FIG. 25 can be incorporated into the return pad60006. According to other aspects, the multiple input-single outputswitching device 60024 shown in FIG. 25 can be incorporated into thesecond conductor/cable 60012 of the electrosurgical system 60000 of FIG.22.

The control of the multiple input-single output switching device 60024was described above in the context of a four input-one output switchingdevice, corresponding to the four sensing devices 60022 shown in FIG.25. It will be appreciated that for aspects where there are more thanfour sensing devices 60022 (e.g., sixteen sensing devices), the outputsignals of the more than more than four sensing devices 60022 will beinput to the multiple input-single output switching device 60024, andmore than two selection signals (e.g., S₀, S₁, S₂ and S₃) are requiredto control the output of the multiple input-single output switchingdevice 60024.

For aspects where the output signals of the sensing devices 60024 areanalog signals, the output of the multiple input-single output switchingdevice 60024 can be converted into a corresponding digital signal by ananalog-to-digital converter 60026 (shown as dashed lines in FIG. 25)prior to the performance of the analysis of the output signals by theapplicable processing circuit.

By incorporating an array of sensing devices 60022 into a plurality ofelectrodes 60016 of the return pad 60006, the position of a nerve of thepatient relative to the electrode tip of the electrosurgical instrument60004 can be determined. The determined nerve location can be presentedto the surgeon, thereby mitigating the likelihood of the surgeoninadvertently injuring or severing the nerve while utilizing theelectrode tip to cut target tissue of the patient 60010.

According to various aspects, the detection of the nerve control signaland/or the movement of an anatomical feature of the patient by thesensing devices 60022 can be performed while the electrodes 60016 of thereturn pad 60006 are coupled to one another or while the electrodes60016 are uncoupled from one another. For example, with regard toperforming the detection when the respective electrodes 60016 of thereturn pad 60006 are uncoupled from one another, after positioning thepatient 60010 on the operating table but before starting a surgicalprocedure, the return pad 60006 can be placed in a “sensing mode” bycontrolling the switching device 60020 shown in FIG. 24 to uncouple therespective electrodes 60016 of the return pad 60006 from one another.While the respective electrodes 60016 are uncoupled from one another, anerve and/or a nerve bundle can be stimulated with an electrosurgicalinstrument 60004 as described above, and the respective output signalsof the sensing devices 60022 of the return pad 60006 can be analyzed asdescribed above to identify where the nerve, nerve bundle and/or nervenexuses associated therewith are located. The locations may be inputinto a monopolar nerve stimulation algorithm profile which may reside,for example, in a memory circuit of the generator 60002, in a memorycircuit of a different generator which is coupled to surgical instrumentother than the electrosurgical instrument 60004, etc. Once the locationsare input into the monopolar nerve stimulation algorithm profile, thelocations are effectively isolated from the capacitive operation of theelectrodes 60016 of the return pad 60006 and are used as sensing nodesof the monopolar nerve stimulation algorithm profile to inform thesurgeon as the surgeon approaches a nerve and/or a nerve bundle whileperforming a tissue cutting procedure. According to various aspects, thesurgeon may be informed of the nearby location of the nerve and/or nervebundle via an audible warning, a visual warning, a vibratory warning,etc.

With regard to performing the detection when the respective electrodes60016 of the return pad 60006 are coupled with one another, according tovarious aspects, as described in more detail below with reference toFIG. 26, the generator 60002 of the electrosurgical system 60000 of FIG.22 can generate a high frequency waveform (the alternating current atradio frequency) which is modulated on a carrier wave, where the carrierwave is of a low enough frequency to stimulate a nerve of the patient.This allows for the sensing of the nerve control signal and/or themovement of an anatomical feature to be concurrent with the capacitivecoupling of the respective electrodes 60016 of the return pad 60006 withthe patient's body. By applying a specific waveform to the patient 60010and sensing a specific response, there is a high level of confidencethat the movement of the anatomical feature is a result of the appliedwaveform and not just some general movement. The modulation can beadjusted over time to stimulate different nerve sizes. According tovarious aspects, the modulation can be varied in amplitude over time inorder to allow the applicable processing circuit to determine thedistance the nerve and/or nerve bundle is from the signal without havingto constantly stimulate the nerve and/or nerve bundle.

FIG. 26 illustrates a method 60030 for concurrently applying a nervestimulation signal and electrosurgical energy to a patient, inaccordance with at least one aspect of the present disclosure. As thefirst step 60032 in this illustrative procedure, the generator 60002generates an alternating current at a radiofrequency level as a highfrequency waveform. According to various aspects, a waveform generatorof the generator 60002 performs this step.

For the second step 60034, the generator 60002 generates a low frequencywaveform which is configured to stimulate a nerve of the patient.According to various aspects, the low frequency waveform is a monopolarnerve control signal and a waveform generator of the generator 60002performs this step.

For the third step 60036, the generator 60002 utilizes the highfrequency waveform generated at step 60032 to modulate the low frequencywaveform generated at step 60034 to form a composite waveform. Accordingto various aspects, a waveform generator of the generator 60002 performsthis step. According to other embodiments, a processing circuit of thegenerator 60002 performs this step.

For the fourth step 60038, the generator 60002 supplies the compositewaveform generated at step 60036 to the electrosurgical instrument60004.

For the fifth step 60040, the electrode (i.e., the active electrode) ofelectrosurgical instrument 60004 applies the composite waveform to thepatient 60010. The high frequency waveform operates to heat the targettissue of the patient 60010 and exits the patient's body before beingreceived by the electrodes 60016 of the return pad 60006. The lowfrequency waveform operates to stimulate a nerve of the patient and/orcause a movement of an anatomical feature of the patient (e.g., a muscletwitch) resulting from application of the nerve control signal.

For the sixth step 60042, the plurality of electrodes 60016 which arecoupled together via the switching device 60020, receive theelectrosurgical energy exiting the patient's body and pass theelectrosurgical energy back to the generator 60002 by way of therespective conductive members 60018, the switching device 60020 and thesecond conductor/cable 60012.

For the seventh step 60044, the sensing devices 60022 detect themonopolar nerve control signal applied to the patient 60010 and/or amovement of an anatomical feature of the patient 60010 (e.g., a muscletwitch) resulting from application of the nerve control signal, andgenerate respective output signals corresponding thereto. The outputs ofthe respective sensing devices 60022 are sampled as described above andforwarded to a processing circuit for analysis. The processing circuitcan be, for example, a processing circuit of the generator 60002 of theelectrosurgical system 60000 of FIG. 22, a processing circuit of a nervemonitoring system which is separate from the generator 60002 of theelectrosurgical system 60000 of FIG. 22, by a processing circuit of thesurgical hub 206, by a processing circuit of the surgical hub 106, etc.

For the eighth step 60046, the applicable processing circuit analyzesthe output signals and determines where the nerve, nerve bundle and/ornerve nexuses associated with the output signals are located. Asdescribed above, according to various aspects, the respective outputsignals can serve as inputs to a monopolar nerve stimulation algorithmwhich is executed by the processing circuit, and the monopolar nervestimulation algorithm operates to help prevent the surgeon from cuttingor damaging the nerve, nerve bundle and/or nerve nexuses.

EXAMPLES

Various aspects of the subject matter described herein are set out inthe following numbered examples.

Example 1

A return pad of an electrosurgical system, the return pad comprising: aplurality of conductive members configured to receive radio frequencycurrent applied to a patient; and a plurality of sensing devicesconfigured to detect at least one of the following: a nerve controlsignal applied to the patient; and a movement of an anatomical featureof the patient resulting from application of the nerve control signal.

Example 2

The return pad of Example 1, wherein the plurality of conductive membersis further configured for capacitive coupling with the patient.

Example 3

The return pad of any one of Examples 1-2, further comprising aswitching device configured for selectively decoupling at least one ofthe plurality of conductive members from another one of the plurality ofconductive members.

Example 4

The return pad of any one of Examples 1-3, further comprising aswitching device configured for selectively decoupling each of theconductive members from one another.

Example 5

The return pad of any one of Examples 1-4, further comprising aswitching device configured for selectively decoupling the plurality ofconductive members from the patient.

Example 6

The return pad of any one of Examples 1-5, further comprising aswitching device configured for selectively decoupling the plurality ofconductive members from a generator.

Example 7

The return pad of any one of Examples 1-6, further comprising aswitching device configured for selectively coupling each of theplurality of conductive members to a generator.

Example 8

The return pad of any one of Examples 1-7, wherein the plurality ofsensing devices are configured as an array of sensing devices.

Example 9

The return pad of any one of Examples 1-8, wherein each of the pluralityof sensing devices is coupled to a corresponding one of the plurality ofconductive members.

Example 10

The return pad of any one of Examples 1-9, wherein each of the pluralityof conductive members is coupled to a corresponding one of the pluralityof sensing devices.

Example 11

The return pad of any one of Examples 1-10, wherein at least one of theplurality of sensing devices comprises one of the following: a pressuresensor; an accelerometer; and a pressure sensor and an accelerometer.

Example 12

The return pad of any one of Examples 1-11, wherein each of theplurality of sensing devices is further configured to output a signalindicative of the detection.

Example 13

An electrosurgical system, comprising: a generator configured to supplyan alternating current at a radiofrequency; an instrument configured toapply the alternating current to a patient; a return pad capacitivelycouplable to the patient, wherein the return pad comprises: a pluralityof conductive members configured to conduct radio frequency current,wherein the plurality of conductive members are capacitively couplableto a patient and are selectively couplable to the generator; a pluralityof sensing devices configured to detect at least one of the following: anerve control signal applied to the patient; and a movement of ananatomical feature of the patient resulting from application of thenerve control signal; and a conductor coupled to the return pad and thegenerator.

Example 14

The electrosurgical system of Example 13, further comprising a multiinput-single output switching device coupled to each of the plurality ofsensing devices.

Example 15

The electrosurgical system of Example 14, further comprising ananalog-to-digital converter coupled to the multi input-single outputswitching device.

Example 16

The electrosurgical system of any one of Examples 1-15, wherein thegenerator is further configured to: generate the alternating current asa high frequency waveform; generate a low frequency waveform which isconfigured to stimulate a nerve of the patient; utilize the highfrequency waveform to modulate the low frequency waveform to form acomposite waveform; and supply the composite waveform to the instrument.

Example 17

The electrosurgical system of any one of Examples 1-16, wherein thegenerator is further configured to amplitude modulate the low frequencywaveform to form the composite waveform.

Example 18

A return pad of an electrosurgical system, the return pad comprising: aplurality of electrodes configured for capacitive coupling with apatient; and an array of sensing devices configured to detect at leastone of the following: a nerve control signal applied to the patient; anda movement of an anatomical feature of the patient resulting fromapplication of the nerve control signal.

Example 19

The return pad of Example 18, wherein each sensing device of the arrayof sensing devices is configured to output a signal indicative of thedetection.

Example 20

The return pad of any one of Examples 18-19, wherein each sensing deviceof the array of sensing devices is positioned on a corresponding one ofthe plurality of electrodes.

While several forms have been illustrated and described, it is not theintention of the applicant to restrict or limit the scope of theappended claims to such detail. Numerous modifications, variations,changes, substitutions, combinations, and equivalents to those forms maybe implemented and will occur to those skilled in the art withoutdeparting from the scope of the present disclosure. Moreover, thestructure of each element associated with the described forms can bealternatively described as a means for providing the function performedby the element. Also, where materials are disclosed for certaincomponents, other materials may be used. It is therefore to beunderstood that the foregoing description and the appended claims areintended to cover all such modifications, combinations, and variationsas falling within the scope of the disclosed forms. The appended claimsare intended to cover all such modifications, variations, changes,substitutions, modifications, and equivalents.

The foregoing detailed description has set forth various forms of thedevices and/or processes via the use of block diagrams, flowcharts,and/or examples. Insofar as such block diagrams, flowcharts, and/orexamples contain one or more functions and/or operations, it will beunderstood by those within the art that each function and/or operationwithin such block diagrams, flowcharts, and/or examples can beimplemented, individually and/or collectively, by a wide range ofhardware, software, firmware, or virtually any combination thereof.Those skilled in the art will recognize that some aspects of the formsdisclosed herein, in whole or in part, can be equivalently implementedin integrated circuits, as one or more computer programs running on oneor more computers (e.g., as one or more programs running on one or morecomputer systems), as one or more programs running on one or moreprocessors (e.g., as one or more programs running on one or moremicroprocessors), as firmware, or as virtually any combination thereof,and that designing the circuitry and/or writing the code for thesoftware and or firmware would be well within the skill of one of skillin the art in light of this disclosure. In addition, those skilled inthe art will appreciate that the mechanisms of the subject matterdescribed herein are capable of being distributed as one or more programproducts in a variety of forms, and that an illustrative form of thesubject matter described herein applies regardless of the particulartype of signal bearing medium used to actually carry out thedistribution.

Instructions used to program logic to perform various disclosed aspectscan be stored within a memory in the system, such as dynamic randomaccess memory (DRAM), cache, flash memory, or other storage.Furthermore, the instructions can be distributed via a network or by wayof other computer readable media. Thus a machine-readable medium mayinclude any mechanism for storing or transmitting information in a formreadable by a machine (e.g., a computer), but is not limited to, floppydiskettes, optical disks, compact disc, read-only memory (CD-ROMs), andmagneto-optical disks, read-only memory (ROMs), random access memory(RAM), erasable programmable read-only memory (EPROM), electricallyerasable programmable read-only memory (EEPROM), magnetic or opticalcards, flash memory, or a tangible, machine-readable storage used in thetransmission of information over the Internet via electrical, optical,acoustical or other forms of propagated signals (e.g., carrier waves,infrared signals, digital signals, etc.). Accordingly, thenon-transitory computer-readable medium includes any type of tangiblemachine-readable medium suitable for storing or transmitting electronicinstructions or information in a form readable by a machine (e.g., acomputer).

As used throughout this description, the term “wireless” and itsderivatives may be used to describe circuits, devices, systems, methods,techniques, communications channels, etc., that may communicate datathrough the use of modulated electromagnetic radiation through anon-solid medium. The term does not imply that the associated devices donot contain any wires, although in some aspects they might not. Thecommunication module may implement any of a number of wireless or wiredcommunication standards or protocols, including but not limited to Wi-Fi(IEEE 802.11 family), WiMAX (IEEE 802.16 family), IEEE 802.20, long termevolution (LTE), Ev-DO, HSPA+, HSDPA+, HSUPA+, EDGE, GSM, GPRS, CDMA,TDMA, DECT, Bluetooth, Ethernet derivatives thereof, as well as anyother wireless and wired protocols that are designated as 3G, 4G, 5G,and beyond. The computing module may include a plurality ofcommunication modules. For instance, a first communication module may bededicated to shorter range wireless communications such as Wi-Fi andBluetooth and a second communication module may be dedicated to longerrange wireless communications such as GPS, EDGE, GPRS, CDMA, WiMAX, LTE,Ev-DO, and others.

As used in any aspect herein, the term “control circuit” may refer to,for example, hardwired circuitry, programmable circuitry (e.g., acomputer processor comprising one or more individual instructionprocessing cores, processing unit, processor, microcontroller,microcontroller unit, controller, digital signal processor (DSP),programmable logic device (PLD), programmable logic array (PLA), orfield programmable gate array (FPGA)), state machine circuitry, firmwarethat stores instructions executed by programmable circuitry, and anycombination thereof. The control circuit may, collectively orindividually, be embodied as circuitry that forms part of a largersystem, for example, an integrated circuit (IC), an application-specificintegrated circuit (ASIC), a system on-chip (SoC), desktop computers,laptop computers, tablet computers, servers, smart phones, etc.Accordingly, as used herein “control circuit” includes, but is notlimited to, electrical circuitry having at least one discrete electricalcircuit, electrical circuitry having at least one integrated circuit,electrical circuitry having at least one application specific integratedcircuit, electrical circuitry forming a general purpose computing deviceconfigured by a computer program (e.g., a general purpose computerconfigured by a computer program which at least partially carries outprocesses and/or devices described herein, or a microprocessorconfigured by a computer program which at least partially carries outprocesses and/or devices described herein), electrical circuitry forminga memory device (e.g., forms of random access memory), and/or electricalcircuitry forming a communications device (e.g., a modem, communicationsswitch, or optical-electrical equipment). Those having skill in the artwill recognize that the subject matter described herein may beimplemented in an analog or digital fashion or some combination thereof.

As used herein a processor or processing unit is an electronic circuitwhich performs operations on some external data source, usually memoryor some other data stream. The term is used herein to refer to thecentral processor (central processing unit) in a system or computersystems (especially systems on a chip (SoCs)) that combine a number ofspecialized “processors.”

As used herein, a system on a chip or system on chip (SoC or SOC) is anintegrated circuit (also known as an “IC” or “chip”) that integrates allcomponents of a computer or other electronic systems. It may containdigital, analog, mixed-signal, and often radio-frequency functions—allon a single substrate. A SoC integrates a microcontroller (ormicroprocessor) with advanced peripherals like graphics processing unit(GPU), Wi-Fi module, or coprocessor. A SoC may or may not containbuilt-in memory.

As used herein, a microcontroller or controller is a system thatintegrates a microprocessor with peripheral circuits and memory. Amicrocontroller (or MCU for microcontroller unit) may be implemented asa small computer on a single integrated circuit. It may be similar to aSoC; an SoC may include a microcontroller as one of its components. Amicrocontroller may contain one or more core processing units (CPUs)along with memory and programmable input/output peripherals. Programmemory in the form of Ferroelectric RAM, NOR flash or OTP ROM is alsooften included on chip, as well as a small amount of RAM.Microcontrollers may be employed for embedded applications, in contrastto the microprocessors used in personal computers or other generalpurpose applications consisting of various discrete chips.

As used herein, the term controller or microcontroller may be astand-alone IC or chip device that interfaces with a peripheral device.This may be a link between two parts of a computer or a controller on anexternal device that manages the operation of (and connection with) thatdevice.

Any of the processors or microcontrollers described herein, may beimplemented by any single core or multicore processor such as thoseknown under the trade name ARM Cortex by Texas Instruments. In oneaspect, the processor may be an LM4F230H5QR ARM Cortex-M4F ProcessorCore, available from Texas Instruments, for example, comprising on-chipmemory of 256 KB single-cycle flash memory, or other non-volatilememory, up to 40 MHz, a prefetch buffer to improve performance above 40MHz, a 32 KB single-cycle serial random access memory (SRAM), internalread-only memory (ROM) loaded with StellarisWare® software, 2 KBelectrically erasable programmable read-only memory (EEPROM), one ormore pulse width modulation (PWM) modules, one or more quadratureencoder inputs (QEI) analog, one or more 12-bit Analog-to-DigitalConverters (ADC) with 12 analog input channels, details of which areavailable for the product datasheet.

In one aspect, the processor may comprise a safety controller comprisingtwo controller-based families such as TMS570 and RM4x known under thetrade name Hercules ARM Cortex R4, also by Texas Instruments. The safetycontroller may be configured specifically for IEC 61508 and ISO 26262safety critical applications, among others, to provide advancedintegrated safety features while delivering scalable performance,connectivity, and memory options.

As used in any aspect herein, the term “logic” may refer to an app,software, firmware and/or circuitry configured to perform any of theaforementioned operations. Software may be embodied as a softwarepackage, code, instructions, instruction sets and/or data recorded onnon-transitory computer readable storage medium. Firmware may beembodied as code, instructions or instruction sets and/or data that arehard-coded (e.g., nonvolatile) in memory devices.

As used in any aspect herein, the terms “component,” “system,” “module”and the like can refer to a computer-related entity, either hardware, acombination of hardware and software, software, or software inexecution.

As used in any aspect herein, an “algorithm” refers to a self-consistentsequence of steps leading to a desired result, where a “step” refers toa manipulation of physical quantities and/or logic states which may,though need not necessarily, take the form of electrical or magneticsignals capable of being stored, transferred, combined, compared, andotherwise manipulated. It is common usage to refer to these signals asbits, values, elements, symbols, characters, terms, numbers, or thelike. These and similar terms may be associated with the appropriatephysical quantities and are merely convenient labels applied to thesequantities and/or states.

A network may include a packet switched network. The communicationdevices may be capable of communicating with each other using a selectedpacket switched network communications protocol. One examplecommunications protocol may include an Ethernet communications protocolwhich may be capable permitting communication using a TransmissionControl Protocol/Internet Protocol (TCP/IP). The Ethernet protocol maycomply or be compatible with the Ethernet standard published by theInstitute of Electrical and Electronics Engineers (IEEE) titled “IEEE802.3 Standard”, published in December, 2008 and/or later versions ofthis standard. Alternatively or additionally, the communication devicesmay be capable of communicating with each other using an X.25communications protocol. The X.25 communications protocol may comply orbe compatible with a standard promulgated by the InternationalTelecommunication Union-Telecommunication Standardization Sector(ITU-T). Alternatively or additionally, the communication devices may becapable of communicating with each other using a frame relaycommunications protocol. The frame relay communications protocol maycomply or be compatible with a standard promulgated by ConsultativeCommittee for International Telegraph and Telephone (CCITT) and/or theAmerican National Standards Institute (ANSI). Alternatively oradditionally, the transceivers may be capable of communicating with eachother using an Asynchronous Transfer Mode (ATM) communications protocol.The ATM communications protocol may comply or be compatible with an ATMstandard published by the ATM Forum titled “ATM-MPLS NetworkInterworking 2.0” published August 2001, and/or later versions of thisstandard. Of course, different and/or after-developedconnection-oriented network communication protocols are equallycontemplated herein.

Unless specifically stated otherwise as apparent from the foregoingdisclosure, it is appreciated that, throughout the foregoing disclosure,discussions using terms such as “processing,” “computing,”“calculating,” “determining,” “displaying,” or the like, refer to theaction and processes of a computer system, or similar electroniccomputing device, that manipulates and transforms data represented asphysical (electronic) quantities within the computer system's registersand memories into other data similarly represented as physicalquantities within the computer system memories or registers or othersuch information storage, transmission or display devices.

One or more components may be referred to herein as “configured to,”“configurable to,” “operable/operative to,” “adapted/adaptable,” “ableto,” “conformable/conformed to,” etc. Those skilled in the art willrecognize that “configured to” can generally encompass active-statecomponents and/or inactive-state components and/or standby-statecomponents, unless context requires otherwise.

The terms “proximal” and “distal” are used herein with reference to aclinician manipulating the handle portion of the surgical instrument.The term “proximal” refers to the portion closest to the clinician andthe term “distal” refers to the portion located away from the clinician.It will be further appreciated that, for convenience and clarity,spatial terms such as “vertical”, “horizontal”, “up”, “down”, “left” and“right” may be used herein with respect to the drawings. However,surgical instruments are used in many orientations and positions, andthese terms are not intended to be limiting and/or absolute.

Modular devices include the modules (as described in connection withFIGS. 3 and 9, for example) that are receivable within a surgical huband the surgical devices or instruments that can be connected to thevarious modules in order to connect or pair with the correspondingsurgical hub. The modular devices include, for example, intelligentsurgical instruments, medical imaging devices, suction/irrigationdevices, smoke evacuators, energy generators, ventilators, insufflators,and displays. The modular devices described herein can be controlled bycontrol algorithms. The control algorithms can be executed on themodular device itself, on the surgical hub to which the particularmodular device is paired, or on both the modular device and the surgicalhub (e.g., via a distributed computing architecture). In someexemplifications, the modular devices' control algorithms control thedevices based on data sensed by the modular device itself (i.e., bysensors in, on, or connected to the modular device). This data can berelated to the patient being operated on (e.g., tissue properties orinsufflation pressure) or the modular device itself (e.g., the rate atwhich a knife is being advanced, motor current, or energy levels). Forexample, a control algorithm for a surgical stapling and cuttinginstrument can control the rate at which the instrument's motor drivesits knife through tissue according to resistance encountered by theknife as it advances.

Those skilled in the art will recognize that, in general, terms usedherein, and especially in the appended claims (e.g., bodies of theappended claims) are generally intended as “open” terms (e.g., the term“including” should be interpreted as “including but not limited to,” theterm “having” should be interpreted as “having at least,” the term“includes” should be interpreted as “includes but is not limited to,”etc.). It will be further understood by those within the art that if aspecific number of an introduced claim recitation is intended, such anintent will be explicitly recited in the claim, and in the absence ofsuch recitation no such intent is present. For example, as an aid tounderstanding, the following appended claims may contain usage of theintroductory phrases “at least one” and “one or more” to introduce claimrecitations. However, the use of such phrases should not be construed toimply that the introduction of a claim recitation by the indefinitearticles “a” or “an” limits any particular claim containing suchintroduced claim recitation to claims containing only one suchrecitation, even when the same claim includes the introductory phrases“one or more” or “at least one” and indefinite articles such as “a” or“an” (e.g., “a” and/or “an” should typically be interpreted to mean “atleast one” or “one or more”); the same holds true for the use ofdefinite articles used to introduce claim recitations.

In addition, even if a specific number of an introduced claim recitationis explicitly recited, those skilled in the art will recognize that suchrecitation should typically be interpreted to mean at least the recitednumber (e.g., the bare recitation of “two recitations,” without othermodifiers, typically means at least two recitations, or two or morerecitations). Furthermore, in those instances where a conventionanalogous to “at least one of A, B, and C, etc.” is used, in generalsuch a construction is intended in the sense one having skill in the artwould understand the convention (e.g., “a system having at least one ofA, B, and C” would include but not be limited to systems that have Aalone, B alone, C alone, A and B together, A and C together, B and Ctogether, and/or A, B, and C together, etc.). In those instances where aconvention analogous to “at least one of A, B, or C, etc.” is used, ingeneral such a construction is intended in the sense one having skill inthe art would understand the convention (e.g., “a system having at leastone of A, B, or C” would include but not be limited to systems that haveA alone, B alone, C alone, A and B together, A and C together, B and Ctogether, and/or A, B, and C together, etc.). It will be furtherunderstood by those within the art that typically a disjunctive wordand/or phrase presenting two or more alternative terms, whether in thedescription, claims, or drawings, should be understood to contemplatethe possibilities of including one of the terms, either of the terms, orboth terms unless context dictates otherwise. For example, the phrase “Aor B” will be typically understood to include the possibilities of “A”or “B” or “A and B.” With respect to the appended claims, those skilledin the art will appreciate that recited operations therein may generallybe performed in any order. Also, although various operational flowdiagrams are presented in a sequence(s), it should be understood thatthe various operations may be performed in other orders than those whichare illustrated, or may be performed concurrently. Examples of suchalternate orderings may include overlapping, interleaved, interrupted,reordered, incremental, preparatory, supplemental, simultaneous,reverse, or other variant orderings, unless context dictates otherwise.Furthermore, terms like “responsive to,” “related to,” or otherpast-tense adjectives are generally not intended to exclude suchvariants, unless context dictates otherwise.

It is worthy to note that any reference to “one aspect,” “an aspect,”“an exemplification,” “one exemplification,” and the like means that aparticular feature, structure, or characteristic described in connectionwith the aspect is included in at least one aspect. Thus, appearances ofthe phrases “in one aspect,” “in an aspect,” “in an exemplification,”and “in one exemplification” in various places throughout thespecification are not necessarily all referring to the same aspect.Furthermore, the particular features, structures or characteristics maybe combined in any suitable manner in one or more aspects.

Any patent application, patent, non-patent publication, or otherdisclosure material referred to in this specification and/or listed inany Application Data Sheet is incorporated by reference herein, to theextent that the incorporated materials is not inconsistent herewith. Assuch, and to the extent necessary, the disclosure as explicitly setforth herein supersedes any conflicting material incorporated herein byreference. Any material, or portion thereof, that is said to beincorporated by reference herein, but which conflicts with existingdefinitions, statements, or other disclosure material set forth hereinwill only be incorporated to the extent that no conflict arises betweenthat incorporated material and the existing disclosure material.

In summary, numerous benefits have been described which result fromemploying the concepts described herein. The foregoing description ofthe one or more forms has been presented for purposes of illustrationand description. It is not intended to be exhaustive or limiting to theprecise form disclosed. Modifications or variations are possible inlight of the above teachings. The one or more forms were chosen anddescribed in order to illustrate principles and practical application tothereby enable one of ordinary skill in the art to utilize the variousforms and with various modifications as are suited to the particular usecontemplated. It is intended that the claims submitted herewith definethe overall scope.

1-20. (canceled)
 21. An electrosurgical pad configured to becapacitively coupled to a patient body, wherein the electrosurgical padcomprises: return electrodes arranged in an array, wherein the returnelectrodes are configured to receive a high-frequency waveform appliedto the patient body, and wherein the return electrodes comprise: a firstreturn electrode; and a second return electrode, wherein the firstreturn electrode and the second return electrode are configured to beselectively coupled to each other and selectively decoupled from eachother; and nerve detection sensors, wherein each nerve detection sensoris configured to detect a low-frequency waveform applied to the patientbody concurrently with the high-frequency waveform, wherein outputsignals from the nerve detection sensors are indicative of a distancebetween the respective nerve detection sensor and a nerve in the patientbody, and wherein the nerve detection sensors comprise: a first nervedetection sensor integrated into the first return electrode; and asecond nerve detection sensor integrated into the second returnelectrode.
 22. The electrosurgical pad of claim 21, wherein thehigh-frequency waveform comprises a tissue treatment waveform, andwherein the low-frequency waveform comprises a nerve control waveform.23. The electrosurgical pad of claim 21, wherein output signals areconfigured to be detected by the first nerve detection sensor and thesecond nerve detection sensor when the first return electrode and thesecond return electrode are coupled to each other.
 24. Theelectrosurgical pad of claim 21, wherein each return electrode is spaceda different distance from the nerve.
 25. The electrosurgical pad ofclaim 21, wherein the array comprises a two-dimensional array.
 26. Theelectrosurgical pad of claim 21, wherein the array comprises anon-concentric array.
 27. The electrosurgical pad of claim 21, whereineach nerve detection sensor is coupled to a corresponding returnelectrode.
 28. The electrosurgical pad of claim 21, wherein each returnelectrode comprises at least one nerve detection sensor.
 29. Anelectrosurgical system, comprising: a generator configured to generatewaveform signals; an instrument configured to supply electrosurgicalenergy from the generator to a patient body; a pad configured to becapacitively coupled to the patient body, wherein the pad comprises:return electrodes arranged in a two-dimensional array, wherein thereturn electrodes comprise a first return electrode and a second returnelectrode, and wherein the first return electrode and the second returnelectrode are configured to be selectively coupled to each other; andnerve detection sensors, wherein each nerve detection sensor isconfigured to detect a current applied to the patient body, whereinoutput signals from the nerve detection sensors are indicative of adistance between the respective nerve detection sensor and a nerve inthe patient body, and wherein the nerve detection sensors comprise: afirst nerve detection sensor integrated into the first return electrode;and a second nerve detection sensor integrated into the second returnelectrode.
 30. The electrosurgical system of claim 29, wherein theinstrument is configured to concurrently supply a high-frequencywaveform and a low-frequency waveform to the patient body.
 31. Theelectrosurgical system of claim 29, wherein the generator is configuredto concurrently generate a high-frequency waveform and a low-frequencywaveform.
 32. The electrosurgical system of claim 31, wherein thegenerator is further configured to modulate the low-frequency waveformwith the high-frequency waveform to form a composite waveform.
 33. Theelectrosurgical system of claim 32, wherein the instrument is configuredto apply the composite waveform to the patient body.
 34. Theelectrosurgical system of claim 33, wherein the low-frequency waveformcomprises a nerve detection signal, and wherein the high-frequencywaveform comprises a tissue treatment signal.
 35. The electrosurgicalsystem of claim 29, further comprising a switching device configured toselectively couple the first return electrode and the second returnelectrode to form a unitary electrode, wherein the unitary electrode isconfigured to minimize a current density applied to the patient body.36. The electrosurgical system of claim 35, wherein the switching deviceis further configured to selectively decouple the first return electrodefrom the second return electrode.
 37. The electrosurgical system ofclaim 29, wherein each return electrode is spaced a different distancefrom the nerve.
 38. The electrosurgical system of claim 29, wherein eachnerve detection sensors is spaced a different distance from the nerve.39. The electrosurgical system of claim 29, wherein the array comprisesa non-concentric array.
 40. An electrosurgical system comprising: anelectrosurgical pad configured to be capacitively coupled to a patientbody, the electrosurgical pad, comprising: return electrodes spaceddifferent distances from a nerve in the patient body, wherein the returnelectrodes are configured to receive tissue treatment waveforms appliedto the patient body by a surgical instrument, wherein the tissuetreatment waveforms comprise an alternating current at a firstfrequency; and nerve detection sensors mounted to the return electrodes,wherein the nerve detection sensors are configured to detect nervedetection waveforms applied to the patient body by the surgicalinstrument, wherein the nerve detection waveforms comprise analternating current at a second frequency, and wherein the secondfrequency is less than the first frequency; and a control circuitconfigured to analyze output signals from the nerve detection sensors todetermine a location of the nerve.
 41. The electrosurgical system ofclaim 40, wherein the tissue treatment waveforms and the nerve detectionwaveforms are concurrently applied to the patient body.